Overview

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