IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in "high-risk" subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeffrey S Heier
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Study eye must have a diagnosis of non-exudative age-related degeneration characterized by the presence of many intermediate sized drusen, 1 or more large drusen, and/or hyperpigmentary changes. Fellow (non-study) eye must have CNV lesion (i.e., leakage on fluorescein angiography and/or subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration OR history of CNV lesion secondary to age-related macular degeneration, as confirmed by current or past treatment or current or past diagnostic imaging.

• Subject must be willing and able to comply with clinic visits and study-related procedures.

• Subject must provide signed informed consent.

• Subject must be able to understand and complete study-related questionnaires. In order to participate in the home monitoring sub-study, subjects must have an approved wireless device (i.e. iPhone, iPad, or iPod running iOS 6.0 or later) or be willing to use a loaned device and have access to a wireless Internet connection for the duration of the study.

Exclusion Criteria:

• Evidence of neovascular AMD in the study eye at time of enrollment or anytime in the past. The reading center must confirm that there is no evidence of neovascular AMD in the study eye prior to enrollment.

• Serous PED of any size in the study eye, as determined by the reading center.

• Previous treatment with verteporfin PDT, anti-VEGF therapy, laser, external beam radiation or other AMD therapy in the study eye.

• History of macular hole in study eye.

• History of vitrectomy in study eye.

• Lens extraction or implantation within the last 3 months.

• Capsulotomy within the last 1 month.

• Lens or other media opacity that would preclude good fundus photography or angiography within the next 2 years.

• Macular edema or signs of diabetic retinopathy more severe than 10 red dots (microaneurysms or blot hemorrhages).

• Retinal changes related to high myopia and/or myopic correction greater than 8.00 diopters spherical equivalent.

• Any progressive ocular disease that would affect visual acuity within the next 2 years.

• Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment.

• Concurrent use of systemic anti-VEGF agents.

• Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye.

• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.

• For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.

• Uncontrolled glaucoma in the study eye (defined as intraocular pressure greater than 25 mmHg) despite treatment with anti-glaucoma medication).

• Subjects who are unable to be photographed to document CNV due to known allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV.

• Subjects with other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy.

• Current treatment for active systemic infection.

• Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders.

• History of recurrent significant infections or bacterial infections.

• Inability to comply with study or follow-up procedures.

• Pregnancy (positive pregnancy test) or lactation