RVO in Japan: Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01377597

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion	Drug: ranibizumab	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ranibizumab intravitreal injection	Drug: ranibizumab

Arm

Intervention/Treatment

Experimental: ranibizumab intravitreal injection

Drug: ranibizumab

Outcome Measures

Primary Outcome Measures

Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline [3 months]

Secondary Outcome Measures

Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit [3 months]
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3 [3 months]
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3 [3 months]
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3 [3 months]
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Japanese 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 ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2

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/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Nagoya	Aichi	Japan	466-8560
2	Novartis Investigative Site	Nagoya	Aichi	Japan	467-8602
3	Novartis Investigative Site	Fukuoka-city	Fukuoka	Japan	812-8582
4	Novartis Investigative Site	Kita-gun	Kagawa	Japan	761-0793
5	Novartis Investigative Site	Suita-city	Osaka	Japan	565-0871
6	Novartis Investigative Site	Ohtsu	Shiga	Japan	520-2192
7	Novartis Investigative Site	Kyoto		Japan	606-8507
8	Novartis Investigative Site	Osaka		Japan	545-8586