Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 monthPhase 2a open label study of Fovista¿ (anti-PDGF therapy) administered in combination with anti-VEGF therapy - OPH1008

IVERIC bio, Inc.0 sites32 target enrollmentJanuary 19, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subfoveal choroidal neovascularization secondary to Age-Related Macular Degeneration (AMD)
Sponsor: IVERIC bio, Inc.
Enrollment: 32
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

January 19, 2021

End Date

January 6, 2017

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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.