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Anti-VEGF Treatment for Prevention of PDR/DME
NCT02634333 · View on ClinicalTrials.gov ↗
Study Summary
Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently would result in favorable visual acuity outcomes. If this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe non-proliferative diabetic retinopathy) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented. The primary objectives of this protocol are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observe
Conditions Studied
Interventions
- PROCEDURE Prompt Sham
- DRUG Prompt aflibercept
- PROCEDURE Deferred laser
- DRUG Deferred aflibercept
Study Locations (20)
California
- Atlantis Eye Care — Huntington Beach
- Loma Linda University Health Care, Department of Ophthalmology — Loma Linda
- East Bay Retina Consultants, Inc. — Oakland
- Southern California Desert Retina Consultants, MC — Palm Desert
- Shashi D Ganti, MD PC — Porterville
- Retina Consultants of Southern California — Redlands
- U.C. Davis Eye Center — Sacramento
- California Retina Consultants — Santa Barbara
- Retinal Consultants of Southern California Medical Group, Inc. — Westlake Village
Florida
- Retina Group of Florida — Fort Lauderdale
- National Ophthalmic Research Institute — Fort Myers
- University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent — Jacksonville
- Florida Retina Institute-Jacksonville — Jacksonville
- Florida Retina Consultants — Lakeland
- Bascom Palmer Eye Institute — Miami
- Magruder Eye Institute — Orlando
- Florida Retina Institute — Orlando
Arizona
- Arizona Retina and Vitreous Consultants — Phoenix
- University of Arizona Medical Center/Department of Ophthalmology — Tucson
Connecticut
- New England Retina Associates — Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2016-01 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02634333
The ClinicalTrials.gov registry entry for NCT02634333 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 399 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 4 interventions — of which Prompt Sham is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02634333 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02634333 about?
NCT02634333 is a clinical study titled "Anti-VEGF Treatment for Prevention of PDR/DME". Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong ev...
What is the current status of trial NCT02634333?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2016-01. Estimated completion is 2022-05-11.
What conditions does trial NCT02634333 study?
This clinical trial studies the following conditions: Diabetic Macular Edema, Diabetic Retinopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02634333?
The interventions under investigation include: Prompt Sham (PROCEDURE), Prompt aflibercept (DRUG), Deferred laser (PROCEDURE), Deferred aflibercept (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02634333?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02634333 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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