Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study ID
NCT01831947
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 15, 2013
Start date
Apr 30, 2010
Status verified
Apr 2013
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab fixed dose
    Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.
  • Experimental: Ranibizumab on demand
    Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.

Primary Outcome Measure

best-corrected visual acuity [ Time Frame: 12 months after start of treatment ]

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