Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

Sponsor
Johannes Gutenberg University Mainz
Study ID
NCT02843490
Phase
PHASE4
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ranibizumab — DRUG
    Three injections (o.5 mg Ranibizumab) within the first three months is followed by an individual therapy interval based on the clinical progress (PRN)

Study Details

Several studies during the last years reported the involvement of anti-retinal autoantibodies in ocular disorders, such as AMD. These studies support the growing evidence of an immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy volunteers. The investigators will evaluate the change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye of nAMD patients treated with Ranibizumab. Neovascular AMD patients (group 1) will be accompanied for 6 months and blood samples will be collected at baseline and monthly until Visit 7 for analysis of antibody profiles. Healthy volunteers (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody profiles. Antibody profiles of all study participants will be analysed to address questions as defined in the outcome measures.

Key Dates

First listed
Jul 25, 2016
Start date
Aug 5, 2016
Status verified
Nov 2017
Primary completion
Aug 17, 2017
Completion
Nov 9, 2017

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ranibizumab treatment of nAMD patients
    nAMD patients will be treated with Ranibizumab (0.5 mg injection) 3 times within three months followed by individual therapy interval based on the clinical progress (PRN) up to 7 times. Analysis of specific biomarker.
  • No Intervention: healthy subjects
    Analysis of specific biomarker.

Primary Outcome Measure

Change in BCVA [ Time Frame: Baseline - 12 weeks ]

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