To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01846299
Phase
PHASE3
Status
Completed

Conditions

  • Macular Edema (ME)

Eligibility Criteria

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

Interventions

  • Sham control — OTHER
    The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
  • Ranibizumab — DRUG
    Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Study Details

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Key Dates

First listed
May 3, 2013
Start date
Oct 31, 2013
Status verified
Apr 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

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

Arms

  • Experimental: Ranibizumab
    A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
  • Sham Comparator: Sham control
    Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.

Primary Outcome Measure

Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye [ Time Frame: Baseline, Month 2 ]

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