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 occlusion

A 3-month, phase III, open-label, single arm, multicenter study assessing the efficacy and safety of 0.5 mg ranibizumab monthly intravitreal injections as monotherapy in patients with visual impairment due to macular edema secondary to branch or central retinal vein occlusion (RVO)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221503

Enrollment

Registered

2011-07-04

Start date

2011-07-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

investigational material(s) Generic name etc : ranibizumab INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline	—

Secondary

Measure	Time frame
-The mean BCVA change from baseline over time to Month 3 -The mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3 -The proportion of patients achieving BCVA improvement of more than 1, more than 5, more than 10, more than 15, and more than 30 letters from baseline to Month 3 -The proportion of patients with a BCVA loss of under 15 letters from baseline to Month 3 -The type, frequency and severity of adverse events compared to baseline	—

Measure

Time frame

-The mean BCVA change from baseline over time to Month 3 -The mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3 -The proportion of patients achieving BCVA improvement of more than 1, more than 5, more than 10, more than 15, and more than 30 letters from baseline to Month 3 -The proportion of patients with a BCVA loss of under 15 letters from baseline to Month 3 -The type, frequency and severity of adverse events compared to baseline

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026