IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD (PRO-CON)

March 29, 2016 updated by: Jeffrey S Heier

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 discretion.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jeffrey S Heier, MD
  • Phone Number: 617-314-2694

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Retina-Vitreous Associates Medical Group
        • Principal Investigator:
          • David S Boyer, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston
        • Contact:
          • Jeffrey S Heier, MD
          • Phone Number: 617-314-2694
        • Contact:
    • New Jersey
      • Edison, New Jersey, United States, 08817
        • Recruiting
        • NJ Retina
        • Contact:
        • Principal Investigator:
          • Sumit P Shah, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Retina Consultants of Houston
        • Contact:
        • Principal Investigator:
          • David M Brown, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal aflibercept injection
Subjects will be randomized to receive intravitreal aflibercept injection every three months for 24 months.
Drug: Intravitreal aflibercept injection
Intravitreal aflibercept injection
Other Names:
  • Eylea
Placebo Comparator: Placebo
Subjects will be randomized to receive sham injection every three months for 24 months.
Drug: Placebo
Sham injection
Other Names:
  • Sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects converting to neovascular AMD at 24 months, characterized by the development of choroidal neovascularization (CNV).
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in visual acuity at 24 months compared to baseline
Time Frame: 24 months
24 months
Percentage of subjects losing less than 15 ETDRS letters at 24 months compared to baseline
Time Frame: 24 months
24 months
Incidence and severity of potential ocular side effects including endophthamitis, retinal detachment, cataract, and intraocular inflammation
Time Frame: up to Month 24
up to Month 24
Incidence and severity of systemic side effects
Time Frame: up to Month 24
up to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeffrey S Heier

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFTe-AMD-1507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Macular Degeneration

Clinical Trials on Intravitreal aflibercept injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe