To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to M… (NCT01846299) | Clinical Trial Compass
CompletedPhase 3
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
Australia181 participantsStarted 2013-10
Plain-language 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).
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
* BCVA must be between ≥ 24 and ≤ 83 letters;
* Visual loss should be mainly due to the presence of any eligible types of ME.
Exclusion Criteria:
* Women of child-bearing potential,
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* Any type of advanced, severe or unstable ocular disease or its reatment;
* ME with a high likelihood of spontaneous resolution.
Other protocol-defined inclusion/exclusion criteria may apply.
What they're measuring
1
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye