Status:
COMPLETED
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetic Macular Edema
Visual Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.
Eligibility Criteria
Inclusion
- Diabetes mellitus 1 or 2, HbA1c \< 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
- Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
- Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
- Central foveal thickness \>250µm (Optical Coherence Tomography).
- Diabetes medication stable in the 3 months prior.
Exclusion
- In the study eye:
- Active intraocular inflammation.
- Any active infection.
- History of uveitis.
- Structural damage within 500 microns of the center of the macula.
- Neovascularization of the iris.
- Uncontrolled glaucoma in either eye (Intraocular Pressure \> 24 mmHg).
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00901186
Start Date
November 1 2009
End Date
August 1 2012
Last Update
March 3 2017
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Almería, Andalusia, Spain, 04009
2
Novartis Investigative Site
Cadiz, Andalusia, Spain, 11009
3
Novartis Investigative Site
Málaga, Andalusia, Spain, 29010
4
Novartis Investigative Site
Mallorca, Balearic Islands, Spain, 07198