IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD (PRO-CON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Drug: Intravitreal aflibercept injection Drug: Placebo||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|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|
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.
Other Name: Sham injection
- Proportion of subjects converting to neovascular AMD at 24 months, characterized by the development of choroidal neovascularization (CNV). [ Time Frame: 24 months ]
- Mean change in visual acuity at 24 months compared to baseline [ Time Frame: 24 months ]
- Percentage of subjects losing less than 15 ETDRS letters at 24 months compared to baseline [ Time Frame: 24 months ]
- Incidence and severity of potential ocular side effects including endophthamitis, retinal detachment, cataract, and intraocular inflammation [ Time Frame: up to Month 24 ]
- Incidence and severity of systemic side effects [ Time Frame: up to Month 24 ]
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
|Contact: Alison M Nowak, BBSemail@example.com|
|Contact: Jeffrey S Heier, MD||617-314-2694|
|United States, California|
|Retina-Vitreous Associates Medical Group||Recruiting|
|Beverly Hills, California, United States, 90211|
|Contact: Sara Ahmed 310-289-2478 ext 1244 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Jeffrey S Heier, MD 617-314-2694|
|United States, New Jersey|
|Edison, New Jersey, United States, 08817|
|Contact: Laura Gadless 732-906-1887 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: David M Brown, MD|
|Principal Investigator:||Jeffrey S Heier, MD||Ophthalmic Consultants of Boston|