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Trial record 1 of 1 for:    NCT02462889
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IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD (PRO-CON)

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ClinicalTrials.gov Identifier: NCT02462889
Recruitment Status : Unknown
Verified March 2016 by Jeffrey S Heier, Ophthalmic Consultants of Boston.
Recruitment status was:  Recruiting
First Posted : June 4, 2015
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Jeffrey S Heier, Ophthalmic Consultants of Boston

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Intravitreal aflibercept injection Drug: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: Eylea

Placebo Comparator: Placebo
Subjects will be randomized to receive sham injection every three months for 24 months.
Drug: Placebo
Sham injection
Other Name: Sham injection




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462889


Contacts
Contact: Alison M Nowak, BBS 617-314-2694 anowak@eyeboston.com
Contact: Jeffrey S Heier, MD 617-314-2694

Locations
United States, California
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact: Sara Ahmed    310-289-2478 ext 1244    sahmed@laretina.com   
Principal Investigator: David S Boyer, MD         
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alison M Nowak, BBA    617-314-2694    anowak@eyeboston.com   
Contact: Jeffrey S Heier, MD    617-314-2694      
United States, New Jersey
NJ Retina Recruiting
Edison, New Jersey, United States, 08817
Contact: Laura Gadless    732-906-1887    lgadless@arcnj.com   
Principal Investigator: Sumit P Shah, MD         
United States, Texas
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Contact: Cassie Cone    713-394-7537    cassandra.cone@houstonretina.com   
Principal Investigator: David M Brown, MD         
Sponsors and Collaborators
Jeffrey S Heier
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Jeffrey S Heier, MD Ophthalmic Consultants of Boston

Responsible Party: Jeffrey S Heier, Director, Vitreoretinal Service, Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier: NCT02462889     History of Changes
Other Study ID Numbers: VGFTe-AMD-1507
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases