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CompletedNCT01934556TREX-DMEUpdated Nov 17, 2020Results posted

A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema

A Phase 1/2 interventional study of Ranibizumab 0.3 mg intravitreal injection and Guided Laser Photocoagulation in Diabetic Macular Edema, sponsored by Palmetto Retina Center, LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Palmetto Retina Center, LLC · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.

Read the detailed description

This research study will compare the visual outcomes between a group of patients who are treated with monthly injections of Ranibizumab 0.3 mg and two groups of patients who are treated with the "Treat and Extend" regimen. One of the "Treat and Extend" groups will also receive laser therapy to determine if this has any additional beneficial effects.

02

Conditions studied

  • Diabetic Macular Edema
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 150 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Palmetto Retina Center, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years of age Patient related considerations
  • For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
  • Although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch. A patient's primary care physician, obstetrician, or gynecologist should be consulted regarding an appropriate form of birth control.
  • Ability and willingness to return for all scheduled visits and assessments

Disease related considerations

  • The presence of center-involving diabetic macular edema on clinical exam and SDOCT
  • Best corrected visual acuity in the study eye, using ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive.
  • Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging.

Exclusion criteria

Exclusion Criteria:

  • General Exclusion Criteria

    • Pregnancy (positive urine pregnancy test) or lactation.
    • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD (Intrauterine Device) , or contraceptive hormone implant or patch.
    • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
    • Participation in another simultaneous medical investigation or trial

Ocular Exclusion Criteria Prior Ocular Treatment

  • History of active proliferative diabetic retinopathy in the study eye on clinical exam
  • History of vitrectomy surgery, submacular surgery, or other intraocular surgical intervention for diabetic macular edema in the study eye
  • Any previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-VEGF drugs including ranibizumab, or device implantation) in the study eye within 90 days of the screening visit.
  • History of prior laser macular photocoagulation more than 90 days prior to screening will be eligible for study inclusion. However, if the investigator does not feel that additional laser photocoagulation can be safely performed or would benefit the patient, then the eye in consideration will be excluded.
  • Evidence of vitreomacular interface abnormality or epiretinal membranes which may be responsible for macular edema

Concurrent Ocular Conditions

  • Any concurrent intraocular condition in the study eye (e.g., cataract or macular degeneration) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA (Best Corrected Visual Acuity) over the 24-month study period.
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia or absence of the posterior capsule in the study eye
  • Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0
  • Uncontrolled glaucoma in the study eye (defined as IOP (Intraocular Pressure) ≥ 30 mmHg despite treatment with anti-glaucoma medication)
  • History of glaucoma-filtering surgery in the study eye
  • History of corneal transplant in the study eye
  • History of pars plana vitrectomy

Concurrent Systemic Conditions

  • Any history of use of systemic anti-VEGF (Vascular Endothelial Growth Factor) agents
  • Uncontrolled blood pressure (defined as systolic > 180 mmHg and/or diastolic > 110 mmHg while patient is sitting) If a patient's initial reading exceeds these values, a second reading may be taken 30 or more minutes later. If the patient's blood pressure needs to be controlled by antihypertensive medication, the patient can become eligible if medication is taken continuously for at least 30 days prior to Day 0.
  • Atrial fibrillation not managed by patient's primary care physician or cardiologist within 3 months of screening visit
  • Women of childbearing potential not using adequate contraception (as defined in the inclusion criteria).

A woman is considered not to be of childbearing potential if she is postmenopausal, defined by amenorrhea for at least 1 year in a woman > 45 years old; or has undergone hysterectomy and/or bilateral oophorectomy.

  • History of stroke within the last 3 months of screening visit
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
  • Current treatment for active systemic infection
  • Active malignancy
  • History of allergy to fluorescein, not amenable to treatment
  • Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the reading center
  • Inability to comply with study or follow-up procedures
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Monthly

    Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months.

    Drug: Ranibizumab 0.3 mg intravitreal injection

  • Active comparator
    TREX

    (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is \> 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.

    Drug: Ranibizumab 0.3 mg intravitreal injection

  • Active comparator
    GILA

    (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is \> 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.

    Drug: Ranibizumab 0.3 mg intravitreal injection · Device: Guided Laser Photocoagulation

Interventions

  • DrugRanibizumab 0.3 mg intravitreal injection

    Also known as: Ranibizumab, Lucentis

  • DeviceGuided Laser Photocoagulation

    Also known as: NAVILAS Guided Laser System

06

What researchers measure

Primary outcomes

  1. Mean Change in Vision at 24 Months

    Mean change in ETDRS (Early Treatment in Diabetic Retinopathy Study) visual acuity at 24 months (week 92-week 107) from Day 0. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning"

    Time frame: 2 Years

Secondary outcomes

  1. Number of Participants With Adverse Events

    Number of Participants with Adverse Events, ocular and non-ocular, in each of the study groups

    Time frame: 2 years

  2. Number of Intravitreal Injections

    Total number of intravitreal injections required during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period.

    Time frame: 2 years

  3. Number of Office Visits

    Total number of office visits and imaging studies performed during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period.

    Time frame: 2 years

  4. Change in Retinal Thickness

    Mean change in central foveal thickness per SDOCT (Spectral Domain Optical Coherence Tomography) from randomization to 12 months (week46 - week 57) and randomization to 24 months (week 92 - week 107) study period.Change at month 24 reported.

    Time frame: 2 years

  5. Percentage of Eyes Gaining or Losing Vision

    Percentage of eyes gaining or losing 3 lines of vision or more and 1 line of vision at 24 months (week 92 - week 107) from Day 0.

    Time frame: 2 years

  6. Percentage of Eyes Which Progress to Proliferative Diabetic Retinopathy

    The percentage of eyes which show progression of proliferative diabetic retinopathy requiring panretinal photocoagulation and/or pars plana vitrectomy over the 24-month study period.

    Time frame: 2 years

  7. Percentage of Eyes Able to Begin Extension Phase Prior to Week 104 End-point Visit.

    The percentage of eyes in the TREX (Treat and Extend) and GILA (Guided Laser) cohorts who are eligible to begin the extension phase prior to week 104 end-point visit.

    Time frame: 2 years

  8. Percentage of Eyes With a Secondary or Tertiary Baseline Retinal Thickness

    For TREX and GILA Cohorts, the time to achieve a "Secondary or Tertiary Baseline" retinal thickness.

    Time frame: 2 years

07

Results

Posted Nov 17, 2020

Participant flow

Participant flow — Overall Study
MilestoneMonthlyTREXGILA
Started306060
Completed254450
Not completed51610
Withdrew: Withdrawal by subject011
Withdrew: Lost to follow-up4107
Withdrew: Death152

Outcome measures

PrimaryMean Change in Vision at 24 Months

Mean change in ETDRS (Early Treatment in Diabetic Retinopathy Study) visual acuity at 24 months (week 92-week 107) from Day 0. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning"

Time frame:
2 Years
Reported as:
Median · units on a scale
Mean Change in Vision at 24 Months
units on a scaleMonthlyTREXGILA
Mean Change in Vision at 24 Months72.5 (67.25 to 81.5)75.0 (69.0 to 80.0)75.0 (69.8 to 82.3)
SecondaryNumber of Participants With Adverse Events

Number of Participants with Adverse Events, ocular and non-ocular, in each of the study groups

Time frame:
2 years
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsMonthlyTREXGILA
Ocular Adverse Events : Blepharitis010
Ocular Adverse Events : Blurred Vision/Vision Loss165
Ocular Adverse Events : Cataract Progression157
Ocular Adverse Events : Chalazion201
Ocular Adverse Events : Conjunctivitis101
Ocular Adverse Events : Conjunctival hemorrhage022
Ocular Adverse Events : Corneal Abrasion001
Ocular Adverse Events : Corneal Edema020
Ocular Adverse Events : Diplopia001
Ocular Adverse Events : Dysphotopsia010
Ocular Adverse Events : Elevated IOP343
Ocular Adverse Events : Epiretinal Membrane111
Ocular Adverse Events : Eye discomfort/discharge6915
Ocular Adverse Events : Eyelid Swelling030
Ocular Adverse Events : Glaucoma Progression011
Ocular Adverse Events : Hollenhorst Plaque010
Ocular Adverse Events : Macular Hole010
Ocular Adverse Events : Optic Neuropathy120
Ocular Adverse Events : Photophobia010
Ocular Adverse Events : Pingueculum100
Ocular Adverse Events : Secondary Cataract322
Ocular Adverse Events : Vitreous floaters767
Ocular Adverse Events : Punctate Keratitis236
Ocular Adverse Events : Retinal Hemorrhage010
Ocular Adverse Events : Vitreomacular Traction110
Ocular Adverse Events : Vitreous Hemorrhage041
Ocular Adverse Events : Vitritis010
Ocular Adverse Events : Worsening Retinopathy122
Nonocular AE: Acute Myocardial Infarction052
Nonocular AE: Angina Pectoris005
Nonocular AE: Arrhythmia213
Nonocular AE: Cardiomyopathy010
Nonocular AE: Congestive Heart Failure024
Nonocular AE: Coronary Artery Disease022
Nonocular AE: Pericardial Effusion001
Nonocular AE: Peripheral Edema168
Nonocular AE: Constipation022
Nonocular AE: Diverticulitis110
Nonocular AE: Diarrhea201
Nonocular AE: Elevated liver enzymes100
Nonocular AE: Nausea/emesis112
Nonocular AE: Gallstones113
Nonocular AE: Esophageal Reflux243
Nonocular AE: Hemorrhoids110
Nonocular AE: Incontinence100
Nonocular AE: Poor dentition233
Nonocular AE: Throat Irritation311
Nonocular AE: Anemia147
Nonocular AE: Hematoma100
Nonocular AE: Thrombocytopenia001
Nonocular AE: Allergy595
Nonocular AE: Appendicitis100
Nonocular AE: Epistaxis101
Nonocular AE: Fever221
Nonocular AE: Gastrointestinal infection134
Nonocular AE: Parotitis001
Nonocular AE: Skin Infection61820
Nonocular AE: Respiratory Infection122214
Nonocular AE: Sinusitis593
Nonocular AE: Urinary Tract Infection421
Nonocular AE: Elevated Creatinine002
Nonocular AE: Fatigue310
Nonocular AE: Graves disease100
Nonocular AE: Hyperammonemia100
Nonocular AE: Hypo/hyperglycemia71214
Nonocular AE: Hyperlipidemia546
Nonocular AE: Hypo/hypercalcemia001
Nonocular AE: Hypo/hyperkalemia015
Nonocular AE: Hypothyroidism/nodule110
Nonocular AE: Hyperparathyroidism001
Nonocular AE: Hyperphosphatemia002
Nonocular AE: Hyperuricemia001
Nonocular AE: Testosterone deficiency210
Nonocular AE: Vitamin D Deficiency132
Nonocular AE: Weight Gain110
Nonocular AE: Arthritis111
Nonocular AE: Fractured Bone239
Nonocular AE: Hernia001
Nonocular AE: Musculoskeletal Pain121618
Nonocular AE: Osteoporosis001
Nonocular AE: Skin burn221
Nonocular AE: Colon Cancer131
Nonocular AE: Lung Cancer101
Nonocular AE: Prostate Cancer010
Nonocular AE: Skin Cancer102
Nonocular AE: Cranial Nerve Palsy002
Nonocular AE: Cerebrovascular Accident003
Nonocular AE: Decreased Hearing011
Nonocular AE: Depression/Anxiety013
Nonocular AE: Dizziness131
Nonocular AE: Headache613
Nonocular AE: Insomnia770
Nonocular AE: Neuropathy101
Nonocular AE: Paresthesia211
Nonocular AE: Syncope/Presyncope122
Nonocular AE: Seizure010
Nonocular AE: Tinnitus011
Nonocular AE: Transient Ischemic Attack001
Nonocular AE: Kidney Stone121
Nonocular AE: Renal Insufficiency116
Nonocular AE: Acute Respiratory Failure111
Nonocular AE: Cough255
Nonocular AE: Dyspnea022
Nonocular AE: Lung Nodule010
Nonocular AE: Pneumonia243
Nonocular AE: Pulmonary Embolism001
Nonocular AE: Rhinorrhea001
Nonocular AE: Sleep apnea001
Nonocular AE: Orthostatic Hypotension010
Nonocular AE: Peripheral Vascular Disease001
Nonocular AE: Worsening Hypertension102126
SecondaryNumber of Intravitreal Injections

Total number of intravitreal injections required during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period.

Time frame:
2 years
Reported as:
Median · Injections
Number of Intravitreal Injections
InjectionsMonthlyTREXGILA
Number of Intravitreal Injections25.0 (24.0 to 26.0)19.0 (13.8 to 24.0)17.0 (12.0 to 21.3)
SecondaryNumber of Office Visits

Total number of office visits and imaging studies performed during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period.

Time frame:
2 years
Reported as:
Median · Visits
Number of Office Visits
VisitsMonthlyTREXGILA
Number of Office Visits25.0 (24.0 to 26.0)19.0 (13.8 to 24.0)17.0 (12.0 to 21.3)
SecondaryChange in Retinal Thickness

Mean change in central foveal thickness per SDOCT (Spectral Domain Optical Coherence Tomography) from randomization to 12 months (week46 - week 57) and randomization to 24 months (week 92 - week 107) study period.Change at month 24 reported.

Time frame:
2 years
Reported as:
Median · Microns
Change in Retinal Thickness
MicronsMonthlyTREXGILA
Change in Retinal Thickness149 (75 to 234)151 (111 to 179)196 (85 to 266)
SecondaryPercentage of Eyes Gaining or Losing Vision

Percentage of eyes gaining or losing 3 lines of vision or more and 1 line of vision at 24 months (week 92 - week 107) from Day 0.

Time frame:
2 years
Reported as:
Count of units · Eyes
Percentage of Eyes Gaining or Losing Vision
EyesMonthlyTREXGILA
1-line vision gainers132832
1-line vision losers513
3-line vision gainers61215
3-line vision losers000
SecondaryPercentage of Eyes Which Progress to Proliferative Diabetic Retinopathy

The percentage of eyes which show progression of proliferative diabetic retinopathy requiring panretinal photocoagulation and/or pars plana vitrectomy over the 24-month study period.

Time frame:
2 years
Reported as:
Count of units · Eyes
Percentage of Eyes Which Progress to Proliferative Diabetic Retinopathy
EyesMonthlyTREXGILA
Percentage of Eyes Which Progress to Proliferative Diabetic Retinopathy122
SecondaryPercentage of Eyes Able to Begin Extension Phase Prior to Week 104 End-point Visit.

The percentage of eyes in the TREX (Treat and Extend) and GILA (Guided Laser) cohorts who are eligible to begin the extension phase prior to week 104 end-point visit.

Time frame:
2 years
Reported as:
Count of units · Eyes
Percentage of Eyes Able to Begin Extension Phase Prior to Week 104 End-point Visit.
EyesMonthlyTREXGILA
Percentage of Eyes Able to Begin Extension Phase Prior to Week 104 End-point Visit.04955
SecondaryPercentage of Eyes With a Secondary or Tertiary Baseline Retinal Thickness

For TREX and GILA Cohorts, the time to achieve a "Secondary or Tertiary Baseline" retinal thickness.

Time frame:
2 years
Reported as:
Count of units · Eyes
Percentage of Eyes With a Secondary or Tertiary Baseline Retinal Thickness
EyesMonthlyTREXGILA
Percentage of Eyes With a Secondary or Tertiary Baseline Retinal Thickness022

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Monthly1/30 (3.3%)11/30 (36.7%)30/30 (100%)
TREX5/60 (8.3%)30/60 (50%)60/60 (100%)
GILA2/60 (3.3%)46/60 (76.7%)60/60 (100%)
Most frequent serious events
Showing 10 of 38
Most frequent serious events
EventMonthlyTREXGILA
HypertensionVascular disorders1/302/606/60
Myocardial InfarctionCardiac disorders0/304/602/60
Congestive Heart FailureCardiac disorders0/302/604/60
Skin/Soft Tissue InfectionInfections and infestations1/303/604/60
PneumoniaRespiratory, thoracic and mediastinal disorders0/304/603/60
Cerebrovascular AccidentNervous system disorders0/300/603/60
Cardiac ArrhythmiaCardiac disorders1/300/601/60
HematomaBlood and lymphatic system disorders1/300/600/60
AllergyImmune system disorders1/300/600/60
AppendicitisGastrointestinal disorders1/300/600/60
Most frequent other events
Showing 10 of 47
Most frequent other events
EventMonthlyTREXGILA
HypertensionVascular disorders10/3021/6026/60
Respiratory InfectionInfections and infestations12/3022/6014/60
Musculoskeletal PainMusculoskeletal and connective tissue disorders12/3016/6018/60
Skin InfectionInfections and infestations6/3018/6020/60
Eye Discomfort/DischargeEye disorders6/309/6015/60
Vitreous FloatersEye disorders7/306/607/60
Hypo/HyperglycemiaEndocrine disorders7/3012/6014/60
InsomniaGeneral disorders7/307/600/60
HeadacheMusculoskeletal and connective tissue disorders6/301/603/60
AllergyImmune system disorders5/309/605/60

Baseline characteristics

Age, Continuous
Age, Continuous(Years)MonthlyTREXGILATotal
Median58.7 (52.5 to 66.0)59.4 (54.2 to 65.2)59.9 (53.3 to 66.7)59.5 (53.5 to 66.0)
Sex: Female, Male
Sex: Female, Male(Participants)MonthlyTREXGILATotal
Female16322472
Male14283678
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MonthlyTREXGILATotal
American Indian or Alaska Native0101
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American12211851
White12313174
More than one race0000
Unknown or Not Reported671124
Region of Enrollment
Region of Enrollment(participants)MonthlyTREXGILATotal
United States306060150
Body-Mass Index
Body-Mass Index(Units of measure "kg/m^2")MonthlyTREXGILATotal
Median32.2 (29.0 to 33.7)31.9 (28.3 to 35.4)30.9 (27.5 to 35.3)31.6 (28.1 to 35.0)
Mean Duration of Diabetes
Mean Duration of Diabetes(Years)MonthlyTREXGILATotal
Mean15 (9.25 to 20)13.5 (9 to 19.25)13.5 (9 to 19.25)14 (9 to 19.25)
Phakic Status
Phakic Status(participants)MonthlyTREXGILATotal
Number234846117
Mean Best Corrected Visual Acuity (ETDRS Letters)
Mean Best Corrected Visual Acuity (ETDRS Letters)(units on a scale)MonthlyTREXGILATotal
Mean67.5 (55.3 to 72.8)65.5 (55.0 to 80.0)67.0 (59.8 to 73.0)66.5 (57.0 to 75.8)

1 further baseline measures are reported on the registry.

08

Study locations

3 sites
  • Retina-Vitreous Associates Medical Group
    Beverly Hills, California 90211, United States
  • Palmetto Retina Center
    West Columbia, South Carolina 29169, United States
  • Retina Consultants of Houston
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Payne JF, Wykoff CC, Clark WL, Bruce BB, Boyer DS, Brown DM; TREX-DME Study Group. Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results. Br J Ophthalmol. 2021 Feb;105(2):253-257. doi: 10.1136/bjophthalmol-2020-316176. Epub 2020 Apr 17. PubMed 32303499 ↗
  • Payne JF, Clark WL, Bruce BB, Wykoff CC, Brown DM, Menke BM, Iverson SM, Allen KF, Boyer DS; Treat & Extend Protocol in Patients with Diabetic Macular Edema Study Group. Retinopathy Regression with Treat and Extend Ranibizumab for Diabetic Macular Edema. Ophthalmology. 2018 Aug;125(8):1304-1306. doi: 10.1016/j.ophtha.2018.03.046. Epub 2018 May 3. No abstract available. PubMed 29729809 ↗
  • Payne JF, Wykoff CC, Clark WL, Bruce BB, Boyer DS, Brown DM; TREX-DME Study Group. Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes. Ophthalmology. 2017 Jan;124(1):74-81. doi: 10.1016/j.ophtha.2016.09.021. Epub 2016 Nov 8. PubMed 27836430 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 23, 2015
  • Informed consent form · Aug 27, 2015

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01934556
Lead sponsor
Palmetto Retina Center, LLC
Responsible party
Sponsor
First posted
Sep 4, 2013
Start date
Nov 2013
Primary completion
Apr 2017
Completion
Apr 2018
Results posted
Nov 17, 2020
Last update
Nov 17, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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