A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02259088
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab (RFB002) — DRUG
    Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
  • Laser — PROCEDURE
    Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
  • Sham injection — DRUG
    Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
  • Sham laser — PROCEDURE
    Imitation of an active laser

Study Details

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

Key Dates

First listed
Oct 8, 2014
Start date
Nov 5, 2014
Status verified
Jan 2019
Primary completion
Jan 17, 2017
Completion
Jan 17, 2017

Study Design

Enrollment
384 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: 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

Primary Outcome Measure

Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 [ Time Frame: Baseline, Monthly from Month 1 through Month 12 ]

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