Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N) (NCT00996437) | Clinical Trial Compass
CompletedPhase 2/3
Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
United States261 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 cove…
What they're measuring
1
Treatment or "Failure" Defined as Vitrectomy
Timeframe: within 112 days of randomization
2
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)