Ophthotech 1002 FOVISTA ADMINISTERED IN COMBINATION WITH LUCENTIS® COMPARED TO LUCENTIS® MONOTHERAPY IN SUBJECTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Overview

Status: Not yet recruiting
Keywords: Age-related macular degeneration
IRB Number: 00067846
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Retinal Diseases, Geriatric Ophthalmology

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of

Fovista™ intravitreous administration when administered in

combination with Lucentis® compared to Lucentis® monotherapy in

subjects with subfoveal choroidal neovascularization secondary to

age-related macular degeneration (AMD).

Principal Investigator: Paul Bernstein
Department: Ophthalmology-Services
Co Investigator:

Contact Information

Name:Kara Halsey
Phone: 213-2034
Email: kara.halsey@utah.edu

Inclusion Criteria

1. Subjects of either gender aged ≥ 50 years.

2. Performance Status ≤ 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale (Appendix 17.4).

3. 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.

4. Provide written informed consent.

5. Ability to comply with study and follow-up procedures and return for all trial visits.

 

 

Ophthalmic Inclusion Criteria  

The following inclusion criteria apply to the study eye:

Active subfoveal choroidal neovascularization (CNV) due to AMD.

Best corrected visual acuity in the study eye between 20/63 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization.

Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be 7 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as leakage on fluorescein angiogram within the anatomic fovea AND/OR subretinal or intraretinal fluid on OCT within the central 1 mm subfield.

Presence on OCT of subretinal hyper-reflective material (SHRM) within the central 1 mm subfield; SHRM is defined as hyper-reflective material located external to the outer retina and internal to the RPE, or, when the RPE is not well defined, internal to Bruch’s membrane.

Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed by the central reading center.

Intraocular pressure (IOP) of 21 mmHg or less

Exclusion Criteria

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.

Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids).

More than 50% of the total lesion size made up of scarring or atrophy as determined by fundus photography with or without fluorescein angiography, with or without OCT. Subjects with any subfoveal scar or subfoveal atrophy directly below the center of the fovea are excluded.

More than 50% of the total lesion size consisting of subretinal hemorrhage.

Presence of retinal angiomatous proliferation (RAP).

Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion or have a vertical height of 400 μm. Presence of pure PED without subretinal hyper-reflective material.

Presence of pigment epithelial tears or rips.

Presence of intraocular inflammation (trace cell or flare), significant epiretinal membrane (causing distortion of macular anatomy and/or opacification), significant vitreomacular traction (causing distortion of macular anatomy), macular hole (full or partial thickness) or vitreous hemorrhage.

Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation.

History of idiopathic or autoimmune-associated uveitis in either eye.

Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 12 months.

Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.

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.

Previous therapeutic radiation in the region of the study eye.

General Exclusion Criteria
Any of the following underlying conditions or diseases including:
• A definitive diagnosis of diabetes mellitus or diabetic retinopathy (regardless of HbA1c level)
• HbA1c v
alue of ≥ 6.5%*
Protocol OPH1002A - Confidential Page 28 06MAR2014
*If the HbA1c value is ≥ 6.5% and ≤ 6.9%, and the patient has no signs or symptoms of diabetes mellitus, has a normal creatinine, has no diabetic retinopathy and no glycosuria, then the patient may have an oral glucose tolerance test (OGTT) at the discretion of the investigator. If the 2-hour glucose value on OGTT is <200 mg/dL, then the patient may be enrolled.1
• History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
•History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 17.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrythmias requiring ongoing treatment.
•Stroke (within 12 months of trial entry).
•Any major surgical procedure within one month of trial entry.

 

Any treatment with an investigational agent in the 60 days prior to randomization for any condition.
 

Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), or to the components or formulation of either Fovista™ or Lucentis®