A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
NCT ID: NCT02259088
Last Updated: 2019-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
384 participants
INTERVENTIONAL
2014-11-05
2017-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ranibizumab (RFB002)
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
Ranibizumab (RFB002)
Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
Sham laser
Imitation of an active laser
Laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
Laser
Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
Sham injection
Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
Interventions
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Ranibizumab (RFB002)
Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
Laser
Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
Sham injection
Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
Sham laser
Imitation of an active laser
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable medication for diabetes within 3 months prior to Visit 1
* Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters
Exclusion Criteria
* Uncontrolled hypertension
* Active ocular infection or intraocular inflammation in any eye
* Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
* Active proliferative diabetic retinopathy in study eye
* Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
* Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
* History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shantou, Guangdong, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Qingdao, Shandong, China
Novartis Investigative Site
Xi’an, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Wenzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Chongqing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Countries
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Other Identifiers
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CRFB002D2305
Identifier Type: -
Identifier Source: org_study_id
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