sing panitumumab with ranibizumab injected into the eye to treat exudative age-related macular degeneratio
Phase 2
- Conditions
- Exudative age-related macular degenerationEye Diseases
- Registration Number
- ISRCTN85022211
- Lead Sponsor
- fa Eye Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1. Best corrected visual acuity of <0.30 (decimal)
2. Foveal retinal thickness (measured from Bruch´s membrane to the inner limiting membrane, i.e. including the retinal pigment epithelium layer) of >300µm
3. Normal intraocular pressure
4. Transparent optical media
5. Absence of any other eye disease (except for cataract or pseudophakia)
6. No previous retinal or vitreoretinal surgery (except for peripheral retinal argon laser coagulation)
Exclusion Criteria
1. Inability to attend the follow-up examinations
2. Inability to understand the purpose and structure of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in the retinal thickness in the foveola, as measured from Bruch´s membrane to the inner limiting membrane (i.e., including the retinal pigment epithelium layer), measured using optical coherence tomography (OCT) of the macula and optic nerve head at the time of the injections/re-injections<br>2. Best Corrected Visual Acuity (BCVA) measured using eye chart (ETDRS chart) at the time of the injections/re-injections<br>
- Secondary Outcome Measures
Name Time Method At baseline, at the time of the injections and re-injections, and at study end using optical coherence tomography: <br>1. Area and volume of subretinal tissue (differentiated between the compartment above and beneath the RPE line), and macular intraretinal and subretinal edema.<br>2. Size of atrophic lesions (geographic atrophies)<br>