Efficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Macular Degeneration
- Sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- best-corrected visual acuity
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).
Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand.
The primary end point of the study is the change of best-corrected visual acuity after 12 month.
Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients with choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD)
- •age 50 and older, male and female
- •membrane \<= 12 papillary diameter
- •visual acuity between 20/320 and 20/40 (ETDRS)
- •written informed consent
Exclusion Criteria
- •known hypersensitivity to the medicinal product under investigation, ingredients or medicinal products with a similar chemical structure
- •participation in another clinical trial within the last 4 weeks
- •unability to understand trial information
- •pregnant or lactating women
- •women with an amenorrhea \< 12 months
- •suspected unability to cooperate
- •detachment of pigment epithelium without membrane detection \>= 50%,retinal angiomatotic proliferation (RAP), presumed ocular histoplasmosis syndrome (POHS), chorioretinal anastomosis (CRA), myopic CNV, CNV following trauma, uveitis, RCS or reasons except AMD
- •rupture of pigment epithelium
- •sub-retinal bleeding \>= 50% of membrane or \>= 1 PD
- •sub-retinal fibrosis or chorio-atrophy
Outcomes
Primary Outcomes
best-corrected visual acuity
Time Frame: 12 months after start of treatment
Change of best-corrected visual acuity before and 12 months after start of treatment with respect to number of letters read on ETDRS-sheets (Early Treatment Diabetes Retinopathy Study Sheets).
Secondary Outcomes
- Fluoresceinangiography(12 months after start of treatment)
- Photography(12 months after treatment start)
- optical coherence tomography (OCT)(12 months after treatment start)
- number of injections(12 months after treatment start)
- quality of life(12 months after treatment start)