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Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N) (N)

Primary Purpose

Vitreous Hemorrhage, Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Saline
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Hemorrhage focused on measuring vitreous, hemorrhage, proliferative, diabetic, retinopathy, intravitreal, ranibizumab, Lucentis, saline, vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subject-level Criteria

Inclusion

To be eligible, the following inclusion criteria must be met:

Age >= 18 years Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria listed below Able and willing to provide informed consent.

Exclusion

A subject is not eligible if any of the following exclusion criteria are present:

A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).

A condition that, in the opinion of the investigator, would preclude subject undergoing elective vitrectomy surgery if indicated during the study.

Participation in an investigational trial that involved treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry.

Known allergy to any component of the study drug. Blood pressure > 180/110 (systolic above 180 or diastolic above 110). Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.

Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.

For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 4 months.

Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.

Study Eye Criteria

The subject must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.

A subject can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and subject before randomization.

The eligibility criteria for a study eye are as follows:

Inclusion

Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, and precluding completion of panretinal photocoagulation (or precluding assessment of completeness of prior PRP).

Immediate vitrectomy not required (investigator and subject are willing to wait at least 8 weeks to see if hemorrhage clears sufficiently without having to proceed to vitrectomy).

Visual acuity is light perception or better.

Exclusion

Prompt vitrectomy indicated, such as because of signs of rhegmatogenous retinal detachment or traction detachment involving the macula present on ultrasound.

Exam evidence of neovascular glaucoma, angle neovascularization, or active neovascularization of the iris (small iris tufts not an exclusion).

History of intravitreal anti-VEGF treatment for vitreous hemorrhage at any time in the past or for an indication other than vitreous hemorrhage in the past 2 months.

History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.

History of vitrectomy. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization.

Aphakia. Uncontrolled glaucoma (in investigator's judgment). Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Sites / Locations

  • Retinal Consultants of AZ
  • University of California, Irvine
  • Loma Linda University Health Care, Dept. of Ophthalmology
  • Southern California Desert Retina Consultants, MC
  • Bay Area Retina Associates
  • Retinal Consultants of Southern California Medical Group, Inc.
  • Denver Health Medical Center
  • New England Retina Associates, PC
  • The George Washington University, Department of Ophthalmology
  • Retina Consultants of Southwest Florida
  • University of Florida College of Med., Department of Ophthalmology
  • Florida Retina Consultants
  • Magruder Eye Institute
  • Sarasota Retina Institute
  • Retina Associates of Sarasota
  • Emory Eye Center
  • Georgia Retina, P.C.
  • Southeast Retina Center, P.C.
  • Retina Associates of Hawaii, Inc.
  • University of Illinois at Chicago Medical Center
  • Raj K. Maturi, M.D., P.C.
  • American Eye Institute
  • Medical Associates Clinic, P.C.
  • Wolfe Eye Clinic
  • Sabates Eye Centers Research Division
  • Retina and Vitreous Associates of Kentucky
  • Paducah Retinal Center
  • Elman Retina Group, P.A.
  • Wilmer Eye Institute at Johns Hopkins
  • Wilmer Eye Institute at Johns Hopkins
  • Retina Consultants of Delmarva, P.A.
  • Joslin Diabetes Center
  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
  • Vitreo-Retinal Associates
  • Retina Center, PA
  • Barnes Retina Institute
  • Delaware Valley Retina Associates
  • The New York Eye and Ear Infirmary/Faculty Eye Practice
  • Mount Sinai School of Medicine, Dept. of Ophthalmology
  • Retina Consultants of Western New York
  • Eye Care for the Adirondacks
  • Retina-Vitreous Surgeons of Central New York, PC
  • University of North Carolina, Dept of Ophthalmology
  • Charlotte Eye Ear Nose and Throat Assoc, PA
  • Piedmont Retina Specialists, PA
  • Mid-America Retina Consultants, P.A.
  • Wake Forest University Eye Center
  • Retina Associates of Cleveland, Inc.
  • Case Western Reserve University
  • OSU Eye Physicians and Surgeons, LLC.
  • Retina Northwest, PC
  • Family Eye Group
  • University of Pennsylvania Scheie Eye Institute
  • Carolina Retina Center
  • Southeastern Retina Associates, PC
  • Southeastern Retina Associates, P.C.
  • West Texas Retina Consultants P.A.
  • Retina Research Center
  • Retina and Vitreous of Texas
  • Baylor Eye Physicians and Surgeons
  • Texas Retina Associates
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retinal Consultants of San Antonio
  • Virginia Retina Center
  • University of Washington Medical Center
  • Medical College of Wiconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline Injection

Ranibizumab

Arm Description

Saline injection at baseline, 4 and 8 weeks

Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks

Outcomes

Primary Outcome Measures

Treatment or "Failure" Defined as Vitrectomy
The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)

Secondary Outcome Measures

Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy
The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test.
Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
Severe Visual Acuity Loss (Defined as <20/200)
Very Severe Visual Acuity Loss (Defined as <20/800)

Full Information

First Posted
October 14, 2009
Last Updated
August 25, 2016
Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00996437
Brief Title
Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
Acronym
N
Official Title
An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.
Detailed Description
In mild to moderate cases of vitreous hemorrhage, panretinal photocoagulation (PRP) is performed when possible to achieve regression of new vessels or at least stabilization of the neovascularization with no further growth in order to decrease the probability of subsequent vitreous hemorrhage while spontaneous absorption of the hemorrhage occurs. In cases in which the hemorrhage is too dense to apply PRP, vitrectomy is considered to remove the hemorrhage and provide a clear media for application of PRP (often as endolaser photocoagulation) as well as eliminate extensive neovascularization and relieve traction retinal detachments. Pars plana vitrectomy was introduced in the 1970s as a surgical intervention in diabetes for non-clearing vitreous hemorrhage, traction retinal detachment or very severe proliferative diabetic retinopathy (PDR). The goal of vitrectomy in such eyes is to remove the hemorrhage and provide a clear media for application of PRP (often as endolaser photocoagulation) as well as eliminate extensive neovascularization and relieve traction retinal detachments. Many advances in instrumentation and technique have resulted in a dramatic reduction in complications over the last few decades, but surgical complications remain including the following: neovascular glaucoma, retinal detachment, fibrinoid syndrome, endophthalmitis and hypotony with subsequent phthisis bulbi. Recovery for the subject can take up to 6 weeks. Increased vascular endothelial growth factor (VEGF) levels have been demonstrated in the retina and vitreous of human eyes with diabetic retinopathy, especially PDR. VEGF has been demonstrated to increase vessel permeability by increasing the phosphorylation of tight junction proteins, and has been shown to increase retinal vascular permeability in in vivo models. Anti-VEGF therapy, therefore, may represent a useful therapeutic modality which targets the underlying pathogenesis of PDR while vitreous hemorrhage clears to facilitate the placement of PRP, potentially avoiding vitrectomy. This study is designed to determine if intravitreal injections of ranibizumab will facilitate clearing of vitreous hemorrhage and avoidance of vitrectomy and its potential complications. Compared with a surgical intervention, use of an intravitreal agent associated with fewer vitrectomies would be preferable because of the reduced costs, reduced time to treatment, reduced intervention time, relatively low risk of side effects, and reduced recovery time. An intravitreal agent also would be a useful alternative for patients who are unwilling to undergo surgery. Furthermore, the study will determine the safety of this medication in the setting of PDR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
Keywords
vitreous, hemorrhage, proliferative, diabetic, retinopathy, intravitreal, ranibizumab, Lucentis, saline, vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline Injection
Arm Type
Placebo Comparator
Arm Description
Saline injection at baseline, 4 and 8 weeks
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline injection of 0.5mg at baseline, 4 and 8 weeks
Primary Outcome Measure Information:
Title
Treatment or "Failure" Defined as Vitrectomy
Description
The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
Time Frame
within 112 days of randomization
Title
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Time Frame
Baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy
Description
The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test.
Time Frame
within 112 days of randomization
Title
Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
Description
Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.
Time Frame
4, 8 and 12 weeks
Title
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
Description
Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.
Time Frame
4, 8 and 12 weeks
Title
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
Time Frame
4, 8 and 12 weeks
Title
Severe Visual Acuity Loss (Defined as <20/200)
Time Frame
4,8 and 12 weeks
Title
Very Severe Visual Acuity Loss (Defined as <20/800)
Time Frame
4,8 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject-level Criteria Inclusion To be eligible, the following inclusion criteria must be met: Age >= 18 years Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria listed below Able and willing to provide informed consent. Exclusion A subject is not eligible if any of the following exclusion criteria are present: A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). A condition that, in the opinion of the investigator, would preclude subject undergoing elective vitrectomy surgery if indicated during the study. Participation in an investigational trial that involved treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry. Known allergy to any component of the study drug. Blood pressure > 180/110 (systolic above 180 or diastolic above 110). Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 4 months. Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study. Study Eye Criteria The subject must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. A subject can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and subject before randomization. The eligibility criteria for a study eye are as follows: Inclusion Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, and precluding completion of panretinal photocoagulation (or precluding assessment of completeness of prior PRP). Immediate vitrectomy not required (investigator and subject are willing to wait at least 8 weeks to see if hemorrhage clears sufficiently without having to proceed to vitrectomy). Visual acuity is light perception or better. Exclusion Prompt vitrectomy indicated, such as because of signs of rhegmatogenous retinal detachment or traction detachment involving the macula present on ultrasound. Exam evidence of neovascular glaucoma, angle neovascularization, or active neovascularization of the iris (small iris tufts not an exclusion). History of intravitreal anti-VEGF treatment for vitreous hemorrhage at any time in the past or for an indication other than vitreous hemorrhage in the past 2 months. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization. History of vitrectomy. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization. Aphakia. Uncontrolled glaucoma (in investigator's judgment). Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam R. Glassman, MS
Organizational Affiliation
Jaeb Center for Health Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdhish Bhavsar, MD
Organizational Affiliation
Retina Center, PA
Official's Role
Study Chair
Facility Information:
Facility Name
Retinal Consultants of AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Loma Linda University Health Care, Dept. of Ophthalmology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Southern California Desert Retina Consultants, MC
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Retinal Consultants of Southern California Medical Group, Inc.
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
New England Retina Associates, PC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
The George Washington University, Department of Ophthalmology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Retina Consultants of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
University of Florida College of Med., Department of Ophthalmology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Magruder Eye Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Retina Associates of Sarasota
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Retina, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Southeast Retina Center, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Associates of Hawaii, Inc.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Illinois at Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Raj K. Maturi, M.D., P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Medical Associates Clinic, P.C.
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52002
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Sabates Eye Centers Research Division
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Retina and Vitreous Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509-1802
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Elman Retina Group, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Wilmer Eye Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9177
Country
United States
Facility Name
Wilmer Eye Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9277
Country
United States
Facility Name
Retina Consultants of Delmarva, P.A.
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Retina Center, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Barnes Retina Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Delaware Valley Retina Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
The New York Eye and Ear Infirmary/Faculty Eye Practice
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai School of Medicine, Dept. of Ophthalmology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Retina Consultants of Western New York
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Eye Care for the Adirondacks
City
Plattsburgh
State/Province
New York
ZIP/Postal Code
12901
Country
United States
Facility Name
Retina-Vitreous Surgeons of Central New York, PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
University of North Carolina, Dept of Ophthalmology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7040
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Assoc, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Piedmont Retina Specialists, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Mid-America Retina Consultants, P.A.
City
Kansas City
State/Province
North Carolina
ZIP/Postal Code
64111
Country
United States
Facility Name
Wake Forest University Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
OSU Eye Physicians and Surgeons, LLC.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Retina Northwest, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Family Eye Group
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601-2644
Country
United States
Facility Name
University of Pennsylvania Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Carolina Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29223
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Southeastern Retina Associates, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
West Texas Retina Consultants P.A.
City
Abilene
State/Province
Texas
ZIP/Postal Code
79605
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina and Vitreous of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Baylor Eye Physicians and Surgeons
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Retina Associates
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Virginia Retina Center
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Medical College of Wiconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25010170
Citation
Bhavsar AR, Torres K, Glassman AR, Jampol LM, Kinyoun JL; Diabetic Retinopathy Clinical Research Network. Evaluation of results 1 year following short-term use of ranibizumab for vitreous hemorrhage due to proliferative diabetic retinopathy. JAMA Ophthalmol. 2014 Jul;132(7):889-90. doi: 10.1001/jamaophthalmol.2014.287. No abstract available.
Results Reference
background
PubMed Identifier
23370902
Citation
Diabetic Retinopathy Clinical Research Network*. Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy. JAMA Ophthalmol. 2013 Mar;131(3):283-93. doi: 10.1001/jamaophthalmol.2013.2015.
Results Reference
result
Links:
URL
http://www.jaeb.org/
Description
Jaeb Center for Health Research

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Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)

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