Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

• Status: Completed
• Trial end date: 2017-11-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johannes Gutenberg University Mainz
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria (patients):

• Male or female

• Age ≥ 50 years

• Subfoveal, juxtafoveal and/or extrafoveal choroidal neovascularisation due to neovascular age-related macular degeneration in the study eye

• Visual acuity of 20/400 (ETDRS charts) or better in the study eye

• Ability of subject to understand character and individual consequences of clinical Trial

• Signed and dated informed consent of the subject must be available before start of any specific trial procedures

• Women with childbearing potential have to practice a medically accepted contraception during trial and a negative pregnancy test (urine) should be existent before trial. Reliable contraception are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicide. Women that are sterile by surgery or for more than two years postmenopausal can participate in the trial.

Inclusion Criteria (healthy subjects):

• Male or female

• Age ≥ 50 years

Exclusion Criteria (patients):

• Inability to obtain fluorescein angiography

• Ophthalmic Surgery or laser < 3 months before enrolment in one or both eyes

• Any history of intravitreal steroids in one or both eyes

• Systemic and/or intravitreal anti-VEGF-treatment < 3 months before enrolment in one or both eyes

• Patients with hypersensitivity against ranibizumab

• Ocular inflammation (including trace or above) or external ocular inflammation in the study eye

• Inability to give informed consent to participate in the study

• Pregnancy and lactation; Woman who are of childbearing age and not using medically acceptable effective contraception.

• Medical or psychological condition that would not permit completion of the trial or signing of informed consent (legal representative accepted)

• Participation in other clinical trials including an investigational drug or device during the present clinical trial or within the last 4 weeks.

Exclusion Criteria (Healthy subjects):

• Ophthalmic Surgery or laser < 3 months before enrolment

• Relevant eye diseases except age-related cataract in one or both eyes

• Inability to give informed consent to participate in the study

• Pregnancy and lactation; Woman who are of childbearing age and not using medically acceptable effective contraception.

• Medical or psychological condition that would not permit completion of the trial or signing of informed consent (legal representative accepted)

• Participation in other clinical trials including an investigational drug or device during the present clinical trial or within the last 4 weeks