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RecruitingNCT03683251PortalUpdated Sep 28, 2026

Extension Study for the Port Delivery System With Ranibizumab (Portal)

A Phase 3 interventional study of PDS Implant with Ranibizumab 100 mg/mL in Neovascular Age-Related Macular Degeneration, sponsored by Hoffmann-La Roche. Recruiting at 165 sites in 15 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Read the detailed description

The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants.

The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

02

Conditions studied

  • Neovascular Age-Related Macular Degeneration
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
  • Ability and willingness to undertake all scheduled visits and assessments
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive measures

Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
  • History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
  • History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications
  • Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"

Sub-study 1

Inclusion Criteria

- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures

Participants must meet the following ocular criteria for the study eye for substudy entry:

  • Diagnosis of exudative nAMD within 2 years prior to the enrollment visit
  • Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit
  • Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:

Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)

  • All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).
  • Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.

Exclusion Criteria Prior Ocular Treatments Study Eye

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
  • Previous treatment with corticosteroid ITV injection
  • Previous intraocular device implantation
  • Previous laser (any type) used for AMD treatment

Either Eye

  • Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
  • Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab

CNV Lesion Charateristics Study Eye

  • Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening
  • Subfoveal fibrosis or subfoveal atrophy

Either Eye

- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia

Concurrent Ocular Conditions Study Eye

  • Retinal pigment epithelial tear
  • Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
  • Active intraocular inflammation (grade trace or above)
  • History of vitreous hemorrhage
  • History of rhegmatogenous retinal detachment
  • History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
  • Aphakia or absence of the posterior capsule
  • Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
  • Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
  • Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
  • Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
  • Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  • History of corneal transplant
  • History of prior vitrectomy surgery and absence of posterior capsule

Either Eye

  • History of idiopathic or autoimmune-associated uveitis
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

Concurrent Systemic Conditions

  • Inability to comply with study schedule or procedures as described in the study protocol
  • Uncontrolled blood pressure
  • History of stroke within the last 3 months prior to informed consent
  • Uncontrolled atrial fibrillation within 3 months of informed consent
  • History of myocardial infarction within the last 3 months prior to informed consent
  • History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator
  • Current systemic treatment for a confirmed active systemic infection
  • Use of any systemic anti-VEGF agents
  • Chronic use of oral corticosteroids
  • Active cancer within 12 months of enrollment
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
  • Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
  • History of albinism
  • Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab

Sub-study 2

Inclusion Criteria:

  • Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye
  • Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center

Exclusion Criteria (Cohort 1 only):

Concurrent Ocular Conditions-Study Eye

  • Any ocular condition that may render the patient at high risk for surgical or treatment complications
  • Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
  • Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
  • History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
  • Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
  • Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
  • Ongoing ocular complications that might affect participant safety

Concurrent Ocular Conditions-Either Eye

  • Suspected or active ocular or periocular infection
  • Any history of uveitis
  • Active blepharitis

Concurrent Systemic Conditions

  • Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
  • Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
  • Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.
  • Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    PDS Implant Cohort 1 (US only)

    Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    PDS Implant Cohort 2 (US only)

    Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    PDS Implant Cohort 3 (US only)

    Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    PDS Implant Cohort 4 (US only)

    Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    PDS Implant Cohort 5 (ex-US only)

    Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    PDS Implant Cohort 6 (ex-US only)

    Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    PDS Implant Cohort 7 (ex-US only)

    Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    Sub-study 1: PDS Implant

    Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    Sub-study 2: Cohort 1

    Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    Sub-study 2: Cohort 2a

    Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

  • Experimental
    Sub-study 2: Cohort 2b

    Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.

    Drug: PDS Implant with Ranibizumab 100 mg/mL

Interventions

  • DrugPDS Implant with Ranibizumab 100 mg/mL

    Will be administered as per the schedule described in individual arm

05

What researchers measure

Primary outcomes

  1. Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)

    Time frame: Baseline up to Week 240

  2. Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)

    Time frame: Baseline up to Week 240

  3. Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study

    Time frame: Baseline up to Week 240

  4. Incidence and Severity of Adverse Device Effects

    Time frame: Baseline up to Week 240

  5. Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects

    Time frame: Baseline up to Week 240

  6. Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit After Implant Insertion Surgery.

    Time frame: Baseline to Week 4

  7. Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs

    Time frame: Baseline to Week 72

  8. Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs

    Time frame: Baseline to Week 72

  9. Sub-study 2: Duration of AESIs

    Time frame: Baseline to Week 72

  10. Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period

    Time frame: Up to Day 37 post re-implantation

  11. Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period

    Time frame: > 37 days post re-implantation (up to approximately Week 72)

  12. Sub-study 2: Duration of Ocular AESIs During the Post-operative Period

    Time frame: Up to Day 37 post re-implantation

  13. Sub-study 2: Duration of Ocular AESIs During the Follow-up Period

    Time frame: > 37 days post re-implantation (up to approximately Week 72)

  14. Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs

    Time frame: Baseline to Week 72

  15. Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs

    Time frame: Baseline to Week 72

  16. Sub-study 2: Duration of Anticipated Serious ADEs

    Time frame: Baseline to Week 72

  17. Sub-study 2: Number of Device Deficiencies

    Time frame: Baseline to Week 72

Secondary outcomes

  1. Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters

    ETDRS = Early Treatment Diabetic Retinopathy Study A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.

    Time frame: Baseline up to Week 240

  2. Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time

    Time frame: Baseline up to Week 240

  3. Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time

    Time frame: Baseline up to Week 240

  4. Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time

    Time frame: Baseline up to Week 240

  5. Change from Baseline in Center Point Thickness (CPT) Over Time

    CPT is defined as the retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT is measured using optical coherence tomography (OCT).

    Time frame: Baseline up to Week 240

  6. Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg During Each Refill-exchange Interval

    Time frame: Baseline up to Week 240

  7. Sub-study 1: Incidence of Ocular Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) in the Study eye

    Time frame: Baseline up to Week 104

  8. Sub-study 1: Incidence of AEs Commonly Seen After Transscleral Cyclophotocoagulation (TS-CPC) for Treatment of Glaucoma in the Study eye

    Time frame: Baseline up to Week 104

  9. Sub-study 1: Time From Surgery to Vitreous Hemorrhage Resolution in the Study eye

    Time frame: Baseline up to Week 104

  10. Sub-study 1: Incidence of Vitreous Hemorrhage Grade 3 and Higher in the Study eye over time

    Time frame: Baseline up to Week 104

  11. Sub-study 1: Distribution of Vitreous Hemorrhage Grade in the Study eye Over Time

    Time frame: Baseline up to Week 104

  12. Sub-study 1: Rate of Vitrectomy in the Study eye

    Time frame: Baseline up to Week 104

  13. Sub-study 1: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score From Baseline Over Time

    Time frame: Baseline up to Week 104

  14. Sub-study 1: Change in BCVA Score From Baseline Over Time

    Time frame: Baseline up to Week 104

  15. Sub-study 1: Change from Baseline in CPT Over Time

    Time frame: Baseline up to Week 104

  16. Sub-study 1: Change From Baseline in Center Subfield Thickness (CST) Over Time

    Time frame: Baseline up to Week 104

  17. Sub-study 2: Number of Participants with Ocular AESIs and Severity of AESIs Following Refill-exchange

    Time frame: Up to approximately Week 72

  18. Sub-study 2: Duration of AESIs Following Refill-exchange

    Time frame: Up to approximately Week 72

  19. Sub-study 2: Number of Participants With ADEs and Severity of ADEs Following Refill-exchange

    Time frame: Up to approximately Week 72

  20. Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs Following Refill-exchange

    Time frame: Up to approximately Week 72

  21. Sub-study 2: Number of Device Deficiencies Following Refill-exchange

    Time frame: Up to approximately Week 72

06

Study locations

73 of 165 sites recruiting
  • Retinal Research Institute, LLC
    Phoenix, Arizona 85014, United States
    Completed
  • Arizona Retina and Vitreous Consultants
    Phoenix, Arizona 85016, United States
    Completed
  • Barnet Dulaney Perkins Eye Center
    Phoenix, Arizona 85016, United States
    Active, not recruiting
  • Associated Retina Consultants
    Phoenix, Arizona 85020, United States
    Completed
  • Retinal Consultants of Arizona
    Phoenix, Arizona 85053, United States
    Completed
  • California Retina Consultants
    Bakersfield, California 93309, United States
    Completed
  • Retina-Vitreous Associates Medical Group
    Beverly Hills, California 90211, United States
    Completed
  • The Retina Partners
    Encino, California 91436, United States
    Active, not recruiting
  • Jacobs Retina center at the Shiley eye Institute UCSD
    La Jolla, California 92037, United States
    Completed
  • Jules Stein Eye Institute/ UCLA
    Los Angeles, California 90095-7000, United States
    Completed
  • N CA Retina Vitreous Assoc
    Mountain View, California 94040, United States
    Completed
  • Retina Consultants, San Diego
    Poway, California 92064, United States
    Completed
  • Retinal Consultants Med Group
    Sacramento, California 95841, United States
    Completed
  • West Coast Retina Medical Group
    San Francisco, California 94109, United States
    Completed
  • UCSF
    San Francisco, California 94158, United States
    Completed
  • Orange County Retina Med Group
    Santa Ana, California 92705, United States
    Active, not recruiting
  • California Retina Consultants
    Santa Barbara, California 93103, United States
    Completed
  • Southwest Retina Consultants
    Durango, Colorado 81303, United States
    Completed
  • Eye Center of Northern CO
    Fort Collins, Colorado 80528, United States
    Completed
  • Colorado Retina Associates, PC
    Lakewood, Colorado 80228, United States
    Completed
  • Retina Group of New England
    Waterford, Connecticut 06385, United States
    Completed
  • Florida Eye Microsurgical Inst
    Boynton Beach, Florida 33426, United States
    Completed
  • National Ophthalmic Research Institute
    Fort Myers, Florida 33912, United States
    Completed
  • Florida Eye Associates
    Melbourne, Florida 32901, United States
    Completed
  • Retina Care Specialists
    Palm Beach Gardens, Florida 33410, United States
    Completed
  • Retina Specialty Institute
    Pensacola, Florida 32503, United States
    Completed
  • Fort Lauderdale Eye Institute
    Plantation, Florida 33324, United States
    Completed
  • Retina Vitreous Assoc of FL
    St. Petersburg, Florida 33711, United States
    Active, not recruiting
  • Southern Vitreoretinal Assoc
    Tallahassee, Florida 32308, United States
    Active, not recruiting
  • Retina Associates of Florida, LLC
    Tampa, Florida 33609, United States
    Completed
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
    Completed
  • Georgia Retina PC
    Marietta, Georgia 30060, United States
    Withdrawn
  • Illinois Retina Associates
    Joliet, Illinois 60435, United States
    Completed
  • University Retina and Macula Associates, PC
    Oak Forest, Illinois 60452, United States
    Completed
  • Wolfe Eye Clinic
    West Des Moines, Iowa 50266, United States
    Completed
  • Retina Associates
    Lenexa, Kansas 66215, United States
    Completed
  • Retina Associates of Kentucky
    Lexington, Kentucky 40509, United States
    Completed
  • Paducah Retinal Center
    Paducah, Kentucky 42001, United States
    Withdrawn
  • Maine Eye Center
    Portland, Maine 04101, United States
    Completed
  • The Retina Care Center
    Baltimore, Maryland 21209, United States
    Completed
  • Johns Hopkins Med
    Baltimore, Maryland 21287, United States
    Active, not recruiting
  • Retina Group of Washington
    Chevy Chase, Maryland 20815, United States
    Completed
  • Retina Specialists
    Towson, Maryland 21204, United States
    Completed
  • Ophthalmic Consultants of Boston
    Boston, Massachusetts 02114, United States
    Completed
  • Foundation for Vision Research
    Grand Rapids, Michigan 49546, United States
    Completed
  • Associated Retinal Consultants
    Royal Oak, Michigan 48073, United States
    Completed
  • VitreoRetinal Surgery, PLLC.
    Minneapolis, Minnesota 55435, United States
    Completed
  • Midwest Vision Research Foundation
    Chesterfield, Missouri 63017, United States
    Completed
  • The Retina Institute - Chesterfield
    St Louis, Missouri 63128, United States
    Completed
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
    Active, not recruiting
  • Envision Ocular, LLC
    Bloomfield, New Jersey 07003, United States
    Completed
  • Retina Associates of NJ
    Teaneck, New Jersey 07666, United States
    Completed
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
    Completed
  • Long Is. Vitreoretinal Consult
    Great Neck, New York 11021, United States
    Completed
  • Retina Assoc of Western NY
    Rochester, New York 14620, United States
    Completed
  • Ophthalmic Consultants of Long Island
    Rockville Centre, New York 11570, United States
    Completed
  • Retina Vit Surgeons/Central NY
    Syracuse, New York 13224, United States
    Completed
  • Char Eye Ear &Throat Assoc
    Charlotte, North Carolina 28210, United States
    Completed
  • Cincinnati Eye Institute
    Cincinnati, Ohio 45242, United States
    Active, not recruiting
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
    Completed
  • OSU Eye Physicians & Surgeons
    Columbus, Ohio 43212, United States
    Active, not recruiting
  • Retina Vitreous Center
    Edmond, Oklahoma 73013, United States
    Completed
  • Retina Northwest
    Portland, Oregon 97221, United States
    Completed
  • Oregon HSU
    Portland, Oregon 97239, United States
    Completed
  • Mid Atlantic Retina - Wills Eye Hospital
    Philadelphia, Pennsylvania 19107, United States
    Completed
  • Palmetto Retina Center
    Florence, South Carolina 29501, United States
    Completed
  • Palmetto Retina Center, LLC
    West Columbia, South Carolina 29169, United States
    Completed
  • Charles Retina Institute
    Germantown, Tennessee 38138, United States
    Completed
  • Tennessee Retina PC
    Nashville, Tennessee 37203, United States
    Active, not recruiting
  • Texas Retina Associates
    Arlington, Texas 76012, United States
    Completed
  • Austin Retina Associates
    Austin, Texas 78705, United States
    Completed
  • Austin Clinical Research LLC
    Austin, Texas 78750, United States
    Active, not recruiting
  • Retina Consultants of Texas
    Bellaire, Texas 77401, United States
    Completed
  • Texas Retina Associates
    Fort Worth, Texas 76104, United States
    Completed
  • Med Center Ophthalmology Assoc
    San Antonio, Texas 78240, United States
    Completed
  • Retina Consultants of Texas
    The Woodlands, Texas 77384, United States
    Completed
  • Retina Associates of Utah, PLLC
    Salt Lake City, Utah 84107, United States
    Active, not recruiting
  • Rocky Mountain Retina
    Salt Lake City, Utah 84107, United States
    Completed
  • Wagner Kapoor Institute
    Virginia Beach, Virginia 23454, United States
    Completed
  • Pacific Northwest Retina
    Silverdale, Washington 98383, United States
    Completed
  • Spokane Eye Clinical Research
    Spokane, Washington 99204, United States
    Completed
  • Oftalmos
    Capital Federal, C1120AAN, Argentina
    Recruiting
  • Centro Oftalmologico Dr. Charles S.A.
    Ciudad Autonoma Buenos Aires, C1121ABB, Argentina
    Recruiting
  • Grupo Laser Vision
    Rosario, S2000DLA, Argentina
    Active, not recruiting
  • Eyeclinic Albury Wodonga
    Albury, New South Wales 2640, Australia
    Active, not recruiting
  • Eye and Retina Consultants
    Hurstville, New South Wales 2220, Australia
    Recruiting
  • LKH-Univ.Klinikum Graz
    Graz, 8036, Austria
    Recruiting
  • Medizinische Universitat Wien
    Vienna, 1090, Austria
    Recruiting
  • UZ Leuven Gasthuisberg
    Leuven, 3000, Belgium
    Completed
  • Botelho Hospital da Visao
    Blumenau, Santa Catarina 89052-504, Brazil
    Recruiting
  • Retina Clinic
    São Paulo, São Paulo 01427-002, Brazil
    Recruiting
  • Universidade Federal de Sao Paulo - UNIFESPX
    São Paulo, São Paulo 04023-062, Brazil
    Recruiting
  • Instituto da Visao IPEPO
    São Paulo, São Paulo 04038-032, Brazil
    Recruiting
  • Hosp de Olhos de Sorocaba
    Sorocaba, São Paulo 18031-060, Brazil
    Recruiting
  • Centre Retine Gallien
    Bordeaux, 33000, France
    Recruiting
  • Hopital de la croix rousse
    Lyon, 69317, France
    Recruiting
  • Centre Paradis Monticelli
    Marseille, 13008, France
    Recruiting
  • Hopital Lariboisiere
    Paris, 75010, France
    Recruiting
  • Fondation Rothschild
    Paris, 75940, France
    Recruiting
  • Universitatsklinikum Bonn
    Bonn, 53127, Germany
    Recruiting

Showing the first 100 of 165 sites across 15 countries.

07

References and documents

Publications

  • Campochiaro PA, Eichenbaum D, Chang MA, Clark WL, Graff JM, Le Pogam S, Cavichini Cordeiro M, Gune S, Rabena M, Singh N, Lin S, Callaway N. Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2025 Feb;9(2):144-155. doi: 10.1016/j.oret.2024.05.021. Epub 2024 Aug 30. PubMed 39209113 ↗
  • Eichenbaum DA, Freeman WR, Chang MA, Brooks L, Chaudhry N, Dadgostar H, McCannel CA, Michels M, Mittra RA, Wolfe JD, Beindl VC, Jaycock P, Bobbala A, Gune S, Spicer G, Callaway N. Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development. Ophthalmol Retina. 2025 Feb;9(2):127-143. doi: 10.1016/j.oret.2024.08.005. Epub 2024 Aug 16. PubMed 39154860 ↗

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

08

Registry details

Key details

Study ID
NCT03683251
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 25, 2018
Start date
Sep 20, 2018
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Reference Study ID Number: GR40549 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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