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 2026-10-27.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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Among 32 studies in Macular Degeneration by Hoffmann-La Roche — 3 open to participants now, 10 under way, 4 of them phase 3. Macular Degeneration · Hoffmann-La Roche.
Among the 32 studies in Macular Degeneration by Hoffmann-La Roche, this one is the 4th largest by planned enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2018, is one of 14 in phase 3, and was the 16th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 236 are open to participants now.
Browse Macular Degeneration studies →3 of the 32 studies in Macular Degeneration by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:
Genentech, Inc. · Sites in United States
Ages 50+
Hoffmann-La Roche · Sites in Austria, Czechia, Denmark and 10 more countries
Ages 50+
By country, each count listing its studies:
Of the 165 Macular Degeneration studies recruiting now, 116 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 8 · Phase 3 14 · Phase 4 2
First in 2002; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Median enrollment 238 across the 28 interventional studies, 568 across the 4 observational. Of the 21 that completed or were terminated, 10 (48%) have results posted.
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Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
5 of the studies in Macular Degeneration by Hoffmann-La Roche that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04657289Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) | 2027-02-04 |
| NCT05562947Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD) | 2027-06-30 |
| NCT05300724Genentech, Inc.An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration | 2027-06-30 |
| NCT06680817Hoffmann-La RocheA Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) | 2027-06-30 |
| NCT04853251Genentech, Inc.A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) | 2027-07-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 32 studies in Macular Degeneration by Hoffmann-La Roche, from their registry updates:
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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.
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.
Inclusion Criteria:
Exclusion Criteria:
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:
Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)
Exclusion Criteria Prior Ocular Treatments Study Eye
Either Eye
CNV Lesion Charateristics Study Eye
Either Eye
- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Concurrent Ocular Conditions Study Eye
Either Eye
Concurrent Systemic Conditions
Sub-study 2
Inclusion Criteria:
Exclusion Criteria (Cohort 1 only):
Concurrent Ocular Conditions-Study Eye
Concurrent Ocular Conditions-Either Eye
Concurrent Systemic Conditions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
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
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
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
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
Will be administered as per the schedule described in individual arm
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Time frame: Baseline up to Week 240
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Time frame: Baseline up to Week 240
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
Incidence and Severity of Adverse Device Effects
Time frame: Baseline up to Week 240
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects
Time frame: Baseline up to Week 240
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
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
Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs
Time frame: Baseline to Week 72
Sub-study 2: Duration of AESIs
Time frame: Baseline to Week 72
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
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)
Sub-study 2: Duration of Ocular AESIs During the Post-operative Period
Time frame: Up to Day 37 post re-implantation
Sub-study 2: Duration of Ocular AESIs During the Follow-up Period
Time frame: > 37 days post re-implantation (up to approximately Week 72)
Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs
Time frame: Baseline to Week 72
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs
Time frame: Baseline to Week 72
Sub-study 2: Duration of Anticipated Serious ADEs
Time frame: Baseline to Week 72
Sub-study 2: Number of Device Deficiencies
Time frame: Baseline to Week 72
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
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Time frame: Baseline up to Week 240
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
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
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
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
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
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
Sub-study 1: Time From Surgery to Vitreous Hemorrhage Resolution in the Study eye
Time frame: Baseline up to Week 104
Sub-study 1: Incidence of Vitreous Hemorrhage Grade 3 and Higher in the Study eye over time
Time frame: Baseline up to Week 104
Sub-study 1: Distribution of Vitreous Hemorrhage Grade in the Study eye Over Time
Time frame: Baseline up to Week 104
Sub-study 1: Rate of Vitrectomy in the Study eye
Time frame: Baseline up to Week 104
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
Sub-study 1: Change in BCVA Score From Baseline Over Time
Time frame: Baseline up to Week 104
Sub-study 1: Change from Baseline in CPT Over Time
Time frame: Baseline up to Week 104
Sub-study 1: Change From Baseline in Center Subfield Thickness (CST) Over Time
Time frame: Baseline up to Week 104
Sub-study 2: Number of Participants with Ocular AESIs and Severity of AESIs Following Refill-exchange
Time frame: Up to approximately Week 72
Sub-study 2: Duration of AESIs Following Refill-exchange
Time frame: Up to approximately Week 72
Sub-study 2: Number of Participants With ADEs and Severity of ADEs Following Refill-exchange
Time frame: Up to approximately Week 72
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
Sub-study 2: Number of Device Deficiencies Following Refill-exchange
Time frame: Up to approximately Week 72
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Showing the first 100 of 165 sites across 15 countries. Choose a country and city above to see the rest.
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
Started Sep 2018 (actual). Primary completion is estimated for Dec 2029, 135 months after the start.
Of 77 industry-sponsored phase 3 interventional studies under Macular Degeneration, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 135 months is above that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 20 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.