This trial is active, not recruiting.

Conditions diabetic macular edema, visual impairment
Treatments ranibizumab, laser
Phase phase 3
Target VEGF
Sponsor Novartis Pharmaceuticals
Start date November 2014
End date March 2017
Trial size 381 participants
Trial identifier NCT02259088, CRFB002D2305


Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
intravitreal ranibizumab injection
ranibizumab Lucentis
intravitreal injections for 3 months then as needed
(Active Comparator)
Laser photocoagulation
laser photocoagulation according to ETDRS guidelines

Primary Outcomes

Mean average BCVA change
time frame: 12 months

Secondary Outcomes

Mean BCVA change by visit
time frame: 12 months
Mean change in Central subfield Thickness (CSFT)
time frame: 12 month
BCVA improvement of ≥ 10 and ≥ 15 letters
time frame: 12 months
BCVA loss of < 10 and < 15 letters
time frame: 12 months
Visual acuity ≥ 73 letters
time frame: month 12
Mean average BCVA change after month 3
time frame: 12 month
Mean change in patient reported visual functioning scale
time frame: 6 and 12 month
Adverse events
time frame: 12 months
Evaluation of treatment patterns
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Other protocol defined inclusion /exclusion criteria may apply

Additional Information

Official title A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients
Description Study to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocaagulation in Chinese patients with visual impairment due to DME. Treatment is driven by achieving vision stabilization
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Novartis.