Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

Phase 4

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Ranibizumab

• Registration Number: NCT02843490
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief 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.

Detailed Description

Several studies during the last years reported the involvement of anti-retinal autoantibodies in ocular disorders, such as retinal vasculitis, retinopathy, retinitis pigmentosa and also 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. AMD patients and healthy volunteers will be recruited at the Department of Ophthalmology of the University Medical Center, Johannes Gutenberg-University Mainz and included based on defined criteria. 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. Ranibizumab is applied according to the manufacturer's recommendations and the "Stellungnahme der DOG, RG und BVA zu aktuellen therapeutischen Möglichkeiten bei der neovaskulären AMD" (December 2012). A loading dose of three injections within the first three months is followed by an individual therapy interval based on the clinical progress (PRN). Re-treatment after the upload of the three initial doses every 4 weeks will be performed in case of progression (PRN) based on the recommendations of the "Stellungnahme der DOG, RG und BVA zu aktuellen therapeutischen Möglichkeiten bei der neovasculären AMD" (December 2012). Healthy volunteers (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody profiles.

Beside the analysis of primary endpoint, the investigators propose to analyze in detail the following questions:

Does the ranibizumab treatment have any effects on antibody profiles found in sera and do these changes correlate with the clinical course of the disease?

Additionally, the patient group can be divided into two subgroups: AMD patients with newly diagnosed neovascular AMD, who have not received anti-VEGF-treatment so far (naïve subjects) and AMD patients with neovascular AMD, who have not received any anti-VEGF treatment 3 months prior to inclusion in the study. This separation may help to answer the question if it is possible to differentiate between ranibizumab responder and non-responder with the help of antibody profiles.

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-25
• Study Start: 2016-08-05
• Primary Completion: 2017-08-17
• Status Verified: 2017-11
• Study Completion: 2017-11-09
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab treatment of nAMD patients	Ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
Change in BCVA	Baseline - 12 weeks	Change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye.

Secondary Outcome Measures

Name	Time	Method
Change in BCVA	Baseline - 24 weeks	Change from Baseline (Visit 1) in BCVA score at Week 24 (visit 7) in the study eye.
Change in retinal thickness	Baseline - 24 weeks	Absolute change from baseline (Visit 1) in central retinal thickness, assessed by OCT at Week 24 (Visit 7) in the study eye.
Number of ranibizumab injections	24 weeks	Mean number of IVT ranibizumab injections needed up to Week 24 (Visit 7) in the study eye.

Trial Locations

Locations (1)

Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Germany