Phase 2a open label study of Fovista¿ (anti-PDGF agent) administered in combination with anti-VEGF therapy in subjects previously treated or treatment-naive.

Phase 1

• Conditions: Subfoveal choroidal neovascularization secondary to Age-Related Macular Degeneration (AMD); MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-000519-42-IT
• Lead Sponsor: IVERIC bio, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-01-06
• Study Start: 2021-01-19
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

OPHTHALMIC INCLUSION CRITERIA: The following inclusion criteria apply to the study eye:

- Best corrected visual acuity in the study eye between 20/40 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization.
Presence of Subfoveal CNV by FA or OCTA, or ICG or OCT (presence of fluid and hypereflective consistent with CNV).

GENERAL INCLUSION CRITERIA:

- Subjects of either gender aged =50 years.
- Women must agree to be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
- Provide written informed consent.
- Ability to comply with study and follow-up procedures and return for all trial visits.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

OPHTHALMIC EXCLUSION CRITERIA:

- Subjects with atrophy or scar within 1 disc area (DA) of the center of the fovea are excluded.
- Prior thermal laser in the macular region, regardless of indication.
- Ocular or periocular infection in the past twelve (12) weeks.
- History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant.
- Previous therapeutic radiation in the region of the study eye.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and biomarker responses of various regimens of Fovista¿ when administered in combination with anti-VEGF agents, in treatment na¿ve and treatment experienced neovascular AMD subjects.;Secondary Objective: NA;Primary end point(s): Biomarker Imaging Endpoints: Modalities: (Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA) - CNV and/or CNV complex analysis with respect to area and/or volume and/or flow. <br><br>Safety Endpoints: - Severe Visual Acuity Loss (Proportion of subjects with >15 letter loss at Months 12 and 18) - Ophthalmic Adverse Events (AEs) - Systemic Adverse Events (AEs) - Laboratory data (blood: hematology, renal function, hepatic function and electrolytes).<br>;Timepoint(s) of evaluation of this end point: Following Month 0-8, 10-14 and 16-18 visits.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA