Pharmacogenomics of antiVEGF in patients with Age-Associated Macular Degeneration.

Phase 1

• Conditions: age-related macular degeneration; MedDRA version: 20.0Level: PTClassification code 10025409Term: Macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-003204-12-ES
• Lead Sponsor: Consorcio PSMAR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-29
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

Patients diagnosed with neovascular Age-related Macular Degeneration and:
•Age of 50 years or older.
•That at the discretion of the ophtalmologist has an indication of receiving treatment with an anti VEGF agent as usual in clinical practice.
•Without previous treatment in the eye under study (no previous treatment for AMD).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

•Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
•Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
•Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
•High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.
•Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.
•Hypersensitivity to the active substance or to the excipients.
•Diabetic retinopathy documented.
•Pregnant or nursing (lactating) women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified