IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD

NCT02462889 | Completed Phase 2 Results

• 1 other identifier: VGFTe-AMD-1507
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Converting to Exudative AMD at 24 Months.

  Percentage of subjects converting to exudative AMD at 24 months as confirmed by independent masked reading center.

  24 months

Secondary Outcomes (4)

• Percentage of Patients Converted to Exudative AMD Who Had Exudative AMD in Fellow Eye ≤ 2 Years at Baseline.

  up to Month 24

• Percentage of Patient Converted to Exudative AMD Based on Presence of Nonexudative CNV.

  up to Month 24

• Mean Change in Best-corrected Visual Acuity at 24 Months Compared to Baseline

  24 months

• Mean Change in Growth of Geographic Atrophy.

  24 months

Study Arms (2)

Intravitreal aflibercept injection

EXPERIMENTAL

Subjects will be randomized to receive intravitreal aflibercept injection every three months for 24 months.

Drug: Intravitreal aflibercept injection

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive sham injection every three months for 24 months.

Drug: Placebo

Interventions

Intravitreal aflibercept injection DRUG

Intravitreal aflibercept injection

Also known as: Eylea

Intravitreal aflibercept injection

Placebo DRUG

Sham injection

Also known as: Sham injection

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeffrey S Heier: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (4)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

NJ Retina

Edison, New Jersey, 08817, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Heier JS, Brown DM, Shah SP, Saroj N, Dang S, Waheed NK, Wykoff CC, Prenner JL, Boyer DS. Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 May 1;139(5):542-547. doi: 10.1001/jamaophthalmol.2021.0221.

  PMID: 33734306 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

No limitations. Trial was completed as planned.

Results Point of Contact

• Title: Jeffrey S. Heier, MD
• Organization: Ophthalmic Consultants of Boston

jsheier@eyeboston.com

617-314-2694

Study Officials

• Jeffrey S Heier, MD

  Ophthalmic Consultants of Boston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Vitreoretinal Service

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)