Status:
COMPLETED
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Macular Edema (ME)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT01846299
Start Date
October 1 2013
End Date
September 1 2015
Last Update
May 23 2016
Active Locations (61)
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1
Novartis Investigative Site
Sydney, New South Wales, Australia, 2000
2
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
3
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
4
Novartis Investigative Site
Hobart, Tasmania, Australia, 7000