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

NCT ID: NCT01377597

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Retinal Vein Occlusion

Keywords

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retinal vein occlusion branch retinal vein occlusion central retinal vein occlusion visual impairment macular edema ranibizumab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ranibizumab intravitreal injection

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

Interventions

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ranibizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharma AG

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Suita, Osaka, Japan

Site Status

Novartis Investigative Site

Ohtsu, Shiga, Japan

Site Status

Countries

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Japan

References

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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. 2017 Feb;95(1):e29-e35. doi: 10.1111/aos.13196. Epub 2016 Sep 22.

Reference Type RESULT
PMID: 27654837 (View on PubMed)

Other Identifiers

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CRFB002E2301

Identifier Type: -

Identifier Source: org_study_id