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Clinical trialNCT02858076CompletedPhase 2/PHASE3Interventional

Anti-VEGF vs. Prompt Vitrectomy for VH From PDR

SponsorJaeb Center for Health ResearchEnrollment205Proliferative Diabetic RetinopathyVitreous Hemorrhage
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

62 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Ubc/vcha Eye Care Centre

    Vancouver, British Columbia, Canada

  • University Health Network - Toronto Western Hospital

    Toronto, Ontario, Canada

United States
  • Retinal Diagnostic Center

    Campbell, California, United States

  • Macula & Retina Institute

    Glendale, California, United States

  • Atlantis Eye Care

    Huntington Beach, California, United States

  • Loma Linda University Health Care, Department of Ophthalmology

    Loma Linda, California, United States

  • Shashi D Ganti, Md Pc

    Porterville, California, United States

  • Florida Retina Consultants

    Lakeland, Florida, United States

  • Southeast Eye Institute, P.A. Dba Eye Associates of Pinellas

    Pinellas Park, Florida, United States

  • Retina Associates of Sarasota

    Sarasota, Florida, United States

  • Retina Associates of Florida, P.A.

    Tampa, Florida, United States

  • Emory Eye Center

    Atlanta, Georgia, United States

  • Southeast Retina Center, P.C.

    Augusta, Georgia, United States

  • Marietta Eye Clinic

    Marietta, Georgia, United States

  • Thomas Eye Group

    Sandy Springs, Georgia, United States

  • Gailey Eye Clinic

    Bloomington, Illinois, United States

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, United States

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, United States

  • Carle Foundation Hospital

    Urbana, Illinois, United States

  • Raj K. Maturi, Md, Pc

    Indianapolis, Indiana, United States

  • John-Kenyon American Eye Institute

    New Albany, Indiana, United States

  • Retina Associates, P.A.

    Shawnee Mission, Kansas, United States

  • Paducah Retinal Center

    Paducah, Kentucky, United States

  • Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center

    West Monroe, Louisiana, United States

  • Elman Retina Group, P.A.

    Baltimore, Maryland, United States

  • Wilmer Eye Institute at Johns Hopkins

    Baltimore, Maryland, United States

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, United States

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan, United States

  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

    Detroit, Michigan, United States

  • Retina Specialists of Michigan

    Grand Rapids, Michigan, United States

  • Retina Center, Pa

    Minneapolis, Minnesota, United States

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota, United States

  • Mid-America Retina Consultants, P.A.

    Kansas City, Missouri, United States

  • the Retina Institute

    St Louis, Missouri, United States

  • Maculacare

    New York, New York, United States

  • the New York Eye and Ear Infirmary/faculty Eye Practice

    New York, New York, United States

  • Weill Cornell Medical College

    New York, New York, United States

  • Retina-Vitreous Surgeons of Central New York, Pc

    Syracuse, New York, United States

  • Kittner Eye Center

    Chapel Hill, North Carolina, United States

22 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

2-mg Intravitreous Aflibercept Injection
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2016
Primary completion
31 Jan 2020
Completion
31 Jan 2020
Last update posted
20 Apr 2021
Registered enrollment
205
Registry id
NCT02858076

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.