A trial to establish the safety and efficacy of administration of Fovista® (Anti-PDGF therapy) in combination with Avastin® compared to Avastin® only in subjects with subfoveal neovascular age-related macular degeneration.

Phase 1

• Conditions: Subfoveal neovascular age-related macular degeneration (AMD); MedDRA version: 19.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 19.0Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-000518-23-CZ
• Lead Sponsor: OPHTHOTECH CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-15
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

* Ophthalmic Inclusion Criteria
The following inclusion criteria apply to the study eye:
- Presence of subfoveal active CNV.
- Best corrected visual acuity in the study eye between 20/63 and 20/200, inclusive.

*General Inclusion Criteria
- Subjects of either gender aged 50 years or over.
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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

Subjects will not be eligible for the trial if any of the following criteria are present in the study eye or systemically:

* Ophthalmic Exclusion Criteria
- Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals.
- Subjects with subfoveal scar or subfoveal atrophy
- Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- Any 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, corneal transplant.

* General Exclusion Criteria
- Diabetes mellitus

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this study are to evaluate the safety and efficacy of Fovista® (E10030 or pegpleranib) intravitreous administration when administered in combination with Avastin® compared to Avastin® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).;Secondary Objective: N/A;Primary end point(s): The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the Month 18 visit.;Timepoint(s) of evaluation of this end point: Following Month 18 visit.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Following Month 18 visit.;Secondary end point(s): Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables.