NCT01225146

Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)

A Phase I Open Label Study of the Safety, Tolerability and Efficacy of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: David M. Brown, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.

Detailed description

The most devastating complication of ischemic CRVO is the development of anterior segment neovascularization and the resulting morbidity from neovascular glaucoma. This complication appears to be directly correlated with intraocular VEGF levels. Currently there is no proven treatment to decrease the formation of rubeosis. Current management of the disease consists of pan-retinal photocoagulation once significant anterior segment neovascularization becomes manifest. This treatment destroys peripheral retina (with peripheral retinal field) and presumably works by eventually lowering ocular VEGF levels which causes secondary regression of rubeosis. As ranibizumab blocks VEGF, this treatment when delivered intraocularly may prevent neo-vascular glaucoma while preserving peripheral visual fields in this patient population. A higher dose of ranibizumab may allow for both a longer duration of treatment effect and potentially more efficacy leading to better outcomes for patients that are somewhat treatment resistant and need continual therapy. Nonclinical and early clinical data indicate that higher doses of ranibizumab up to and including 2.0 mg are safe and tolerated by patients.

Conditions

• Ischemia
• Retinal Vein Occlusion
• Pathologic Processes
• Retinal Diseases
• Eye Diseases

Interventions

Type	Name	Description
DRUG	ranibizumab	Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-10-20
• Last updated: 2017-08-14
• Results posted: 2017-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study