IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD

Therapuetic Areas:Ophthalmology
Age Range:Any
Start Date:June 2015
End Date:December 2018
Contact:Alison M Nowak, BBS

Use our guide to learn which trials are right for you!

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 Eyes

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.

128 subjects will be enrolled in the trial and randomized in a 1:1 ratio to receive either
IAI every three months for 24 months or sham injections. Enrollment will be stratified in
order to ensure a balance between the two treatment groups for subjects who were diagnosed
with exudative AMD within the past two years versus those diagnosed more than two years
prior to Baseline.

Study assessments will be conducted at required visits every three months and include
manifest refraction and ETDRS visual acuity testing, slit lamp exam and dilated fundus exam,
spectral-domain optical coherence tomography (SD-OCT) using Avanti device, and OCT
angiography using Avanti AngioVueTM, and fluorescein angiography. Fundus photography will
also be performed at Baseline, Month 12 and Month 24 visits.

In the event of conversion to neovascular AMD in the study eye at any point during the
study, the Investigator will treat the subject with IAI at a frequency per his/her

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

- 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

- 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

- 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

- 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

- History of recurrent significant infections or bacterial infections.

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

- Pregnancy (positive pregnancy test) or lactation
We found this trial at
Beverly Hills, California 90211
Principal Investigator: David S Boyer, MD
Phone: 310-289-2478
Beverly Hills, CA
Click here to add this to my saved trials
Boston, Massachusetts 02114
Phone: 617-314-2694
Boston, MA
Click here to add this to my saved trials
Edison, New Jersey 08820
Principal Investigator: Sumit P Shah, MD
Phone: 732-906-1887
Edison, NJ
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: David M Brown, MD
Phone: 713-394-7537
Houston, TX
Click here to add this to my saved trials