Conditions: Macular Edema (ME)
Keywords: Vision Impairment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 181
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Sham control intervention 2: Ranibizumab
Intervention descriptions: intervention 1: 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. intervention 2: Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Protocol document: