Rubeosis Anti-VEGF (RAVE) Trial for Ischemic Central Retinal Vein Occlusion
2 other identifiers
interventional
20
1 country
1
Brief Summary
The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis) injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic central retinal vein occlusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 30, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 14, 2013
March 1, 2013
5.7 years
November 30, 2006
March 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Preservation of 5Ve isopter Goldmann visual field versus baseline at 1 year
12 and 24 months
Estimate the % of subjects progressing to neovascular glaucoma requiring pan-retinal photocoagulation or glaucoma surgery after treatment with ranibizumab (comparing 0.3mg to 0.5mg doses)
12 and 24 mponths
Secondary Outcomes (10)
Assess the systemic and local safety of 0.3mg and 0.5mg of ranibizumab in patients with ischemic CRVO
12 and 24 months
Assess improvement from baseline in Visual Acuity at 1 year
12 and 24 months
Assess the impact on retinal thickness and volume (as measured by OCT)
12 and 24 months
Assess the impact of ranibizumab (0.3mg and 0.5mg) on time to improvement in visual acuity
12 and 24 months
Asses the impact of ranibizumab (0.3mg and 0.5mg) on time to improvement in retinal thickness
12 and 24 months
- +5 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR500 micrograms of ranibizumab
2
ACTIVE COMPARATOR300 microgram ranibizumab
Interventions
500 microgram intravitreal injection for 8 months or 300 microgram intravitreal injection for 8 months
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Three of the following clinical tests must be present to demonstrate ischemic CRVO:
- VA 20/200 or worse
- RAPD 0.9 LU or worse
- Loss of 1-2e isopter on Goldmann Visual field (Kwon et al. 2001)
- ERG demonstrating b wave amplitude less than 60% of A wave
You may not qualify if:
- Angle neovascularization greater than 3 clock hours with IOP over 30 (Neovascular glaucoma)
- Any previous retinal laser photocoagulation to the study eye
- Any previous intravitreal injection in study eye (triamcinolone or other)
- Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
- Intracapsular cataract extraction (posterior capsule needs to be present)
- Previous history of retinal detachment in study eye
- Any previous radiation treatments to head/ neck
- Inability to assess iris neovascularization (corneal opacity precluding gonioscopy)
- Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
- Significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy)
- Pregnancy (positive pregnancy test)
- Prior enrollment in any study for vein occlusion in the study eye
- Participation in another simultaneous medical investigator or trial
- Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., DME AMD, ocular histoplasmosis, or pathologic myopia)
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vitreoretinal Consultants
Houston, Texas, 77030, United States
Related Publications (2)
Wykoff CC, Brown DM, Croft DE, Major JC Jr, Wong TP. Progressive retinal nonperfusion in ischemic central retinal vein occlusion. Retina. 2015 Jan;35(1):43-7. doi: 10.1097/IAE.0000000000000277.
PMID: 25102193DERIVEDWykoff CC, Brown DM, Croft DE, Wong TP. Two Year SAVE Outcomes: 2.0 mg ranibizumab for recalcitrant neovascular AMD. Ophthalmology. 2013 Sep;120(9):1945-6.e1. doi: 10.1016/j.ophtha.2013.06.030. No abstract available.
PMID: 24001533DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David M Brown, MD
Vitreoretinal Consultants
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
November 30, 2006
First Posted
December 4, 2006
Study Start
May 1, 2005
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 14, 2013
Record last verified: 2013-03