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Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

NCT02843490 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

Ranibizumab

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Christina Korb, MD · Johannes Gutenberg-University Mainz, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-05
Primary Completion
2017-08-17
Completion
2017-11-09

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02843490 on ClinicalTrials.gov