Status:
COMPLETED
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetic Macular Edema
Visual Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
Detailed Description
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME...
Eligibility Criteria
Inclusion
- Key
- Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
- 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
- Key
Exclusion
- Stroke or myocardial infarction less than 3 months prior to screening visit
- 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
Key Trial Info
Start Date :
November 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2017
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT02259088
Start Date
November 5 2014
End Date
January 17 2017
Last Update
February 1 2019
Active Locations (28)
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1
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100044
2
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100191
3
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100730
4
Novartis Investigative Site
Guangzhou, Guangdong, China, 510060