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

Retinal Vein Occlusion Clinical Trial

— RVO in Japan  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377597
• Other study ID #: CRFB002E2301
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2011
• Last updated: November 16, 2016
• Start date: June 2011
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion
• Vision Disorders

Intervention

Drug:
• ranibizumab

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Ohtsu	Shiga
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Suita-city	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kamei M, Terasaki H, Yoshimura N, Shiraga F, Ogura Y, Grotzfeld AS, Pilz S, Ishibashi T. Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. Acta Ophthalmol. 2016 Sep 22. doi: 10.1111/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit		3 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events		3 months	No

External Links

•   Results for CRFB002E2301 from the Novartis Clinical Trials Website