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Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
NCT02858076 · View on ClinicalTrials.gov ↗
Study Summary
Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.
Conditions Studied
Interventions
- DRUG 2-mg Intravitreous Aflibercept Injection
- PROCEDURE Prompt Vitrectomy Plus Panretinal Photocoagulation
Study Locations (20)
California
- Retinal Diagnostic Center — Campbell
- Macula & Retina Institute — Glendale
- Atlantis Eye Care — Huntington Beach
- Loma Linda University Health Care, Department of Ophthalmology — Loma Linda
- Shashi D Ganti, MD PC — Porterville
Florida
- Florida Retina Consultants — Lakeland
- Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park
- Retina Associates of Sarasota — Sarasota
- Retina Associates of Florida, P.A. — Tampa
Georgia
- Emory Eye Center — Atlanta
- Southeast Retina Center, P.C. — Augusta
- Marietta Eye Clinic — Marietta
- Thomas Eye Group — Sandy Springs
Illinois
- Gailey Eye Clinic — Bloomington
- Northwestern Medical Faculty Foundation — Chicago
- University of Illinois at Chicago Medical Center — Chicago
- Carle Foundation Hospital — Urbana
Indiana
- Raj K. Maturi, MD, PC — Indianapolis
- John-Kenyon American Eye Institute — New Albany
Kansas
- Retina Associates, P.A. — Shawnee Mission
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2016-11 |
| Est. Completion | 2020-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02858076
The ClinicalTrials.gov registry entry for NCT02858076 describes a study currently listed as completed. It is categorized as Phase 2, 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 205 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 Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions — of which 2-mg Intravitreous Aflibercept Injection 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: NCT02858076 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Georgia. 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 NCT02858076 about?
NCT02858076 is a clinical study titled "Anti-VEGF vs. Prompt Vitrectomy for VH From PDR". Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention ...
What is the current status of trial NCT02858076?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2016-11. Estimated completion is 2020-01.
What conditions does trial NCT02858076 study?
This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy, Vitreous Hemorrhage. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02858076?
The interventions under investigation include: 2-mg Intravitreous Aflibercept Injection (DRUG), Prompt Vitrectomy Plus Panretinal Photocoagulation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02858076?
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 NCT02858076 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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