Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
Public ClinicalTrials.gov record NCT02858076. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02858076
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 205 participants
Conditions and interventions
Interventions
- 2-mg Intravitreous Aflibercept Injection Drug
- Prompt Vitrectomy Plus Panretinal Photocoagulation Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- Dec 31, 2019
- Completion
- Dec 31, 2019
- Last update posted
- Apr 19, 2021
2016 – 2020
United States locations
- U.S. sites
- 60
- U.S. states
- 24
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Diagnostic Center | Campbell | California | 95008 | — |
| Macula & Retina Institute | Glendale | California | 91203 | — |
| Atlantis Eye Care | Huntington Beach | California | 92647 | — |
| Loma Linda University Health Care, Department of Ophthalmology | Loma Linda | California | 92354 | — |
| Shashi D Ganti, MD PC | Porterville | California | 93257 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| Southeast Eye Institute, P.A. dba Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | — |
| Retina Associates of Sarasota | Sarasota | Florida | 34233 | — |
| Retina Associates of Florida, P.A. | Tampa | Florida | 33609 | — |
| Emory Eye Center | Atlanta | Georgia | 30322 | — |
| Southeast Retina Center, P.C. | Augusta | Georgia | 30909 | — |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | — |
| Thomas Eye Group | Sandy Springs | Georgia | 30328 | — |
| Gailey Eye Clinic | Bloomington | Illinois | 61704 | — |
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | — |
| University of Illinois at Chicago Medical Center | Chicago | Illinois | 60612 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Raj K. Maturi, MD, PC | Indianapolis | Indiana | 42690 | — |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | — |
| Retina Associates, P.A. | Shawnee Mission | Kansas | 66204 | — |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | — |
| Eye Associates of Northeast Louisiana dba Haik Humble Eye Center | West Monroe | Louisiana | 71291 | — |
| Elman Retina Group, P.A. | Baltimore | Maryland | 21237 | — |
| Wilmer Eye Institute at Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Valley Eye Physicians and Surgeons | Ayer | Massachusetts | 01432 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Kellogg Eye Center, University of Michigan | Ann Arbor | Michigan | 48105 | — |
| Henry Ford Health System, Dept of Ophthalmology and Eye Care Services | Detroit | Michigan | 48202 | — |
| Retina Specialists of Michigan | Grand Rapids | Michigan | 49546 | — |
| Retina Center, PA | Minneapolis | Minnesota | 55404 | — |
| Mayo Clinic Department of Ophthalmology | Rochester | Minnesota | 55905 | — |
| Mid-America Retina Consultants, P.A. | Kansas City | Missouri | 64111 | — |
| The Retina Institute | St Louis | Missouri | 63128 | — |
| The New York Eye and Ear Infirmary/Faculty Eye Practice | New York | New York | 10003 | — |
| MaculaCare | New York | New York | 10021 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Retina-Vitreous Surgeons of Central New York, PC | Syracuse | New York | 13224 | — |
| Kittner Eye Center | Chapel Hill | North Carolina | 27517 | — |
| Charlotte Eye, Ear, Nose and Throat Assoc., PA | Charlotte | North Carolina | 28210 | — |
| Retina Associates of Cleveland, Inc. | Beachwood | Ohio | 44122 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Retina Vitreous Center | Edmond | Oklahoma | 73013 | — |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Retina, LLP | Eugene | Oregon | 97401 | — |
| Retina Northwest, PC | Portland | Oregon | 97221 | — |
| Casey Eye Institute | Portland | Oregon | 97239 | — |
| Retina Vitreous Consultants | Monroeville | Pennsylvania | 15146 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | — |
| Southeastern Retina Associates | Chattanooga | Tennessee | 37421 | — |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37909 | — |
| Southwest Retina Specialists | Amarillo | Texas | 79106 | — |
| Retina Research Center | Austin | Texas | 78705 | — |
| Retina and Vitreous of Texas | Houston | Texas | 77025 | — |
| Baylor Eye Physicians and Surgeons | Houston | Texas | 77030 | — |
| Texas Retina Associates | Lubbock | Texas | 79424 | — |
| Valley Retina Institute | McAllen | Texas | 78503 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | — |
| Spokane Eye Clinic | Spokane | Washington | 99204 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02858076, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 19, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02858076 live on ClinicalTrials.gov.