Efficacy and safety of 0.5 mg ranibizumab monthly intravitreal injections as monotherapy in patients with visual impairment due to macular edema secondary to retinal vein occlusio

Phase 3

• Conditions: visual impairment due to macular edema secondary to branch or central retinal vein occlusion

• Registration Number: JPRN-jRCT2080221503
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
-Diagnosis within 12 months prior to Visit 1
-Best-corrected visual acuity (BCVA):
CRVO; BCVA score between 24 and 73 letters ETDRS
BRVO; BCVA score between 19 and 73 letters ETDRS

Exclusion Criteria

-Pregnant or nursing women
-History of stroke
-Uncontrolled blood pressure
-Active ocular infection or intraocular inflammation in either eye
-Uncontrolled glaucoma in either eye
-Neovascularization of the iris or neovascular glaucoma in either eye
-Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
-Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
-Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
-Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
-Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
-Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
-Use of any intra-ocular corticosteroid implants in the study eye
Other protocol-defined inclusion and exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified