IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Jeffrey S Heier
Study ID
NCT02462889
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Oct 2025
Primary completion
Mar 31, 2019
Completion
Mar 31, 2019

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intravitreal aflibercept injection
    Subjects will be randomized to receive intravitreal aflibercept injection every three months for 24 months.
  • Placebo Comparator: Placebo
    Subjects will be randomized to receive sham injection every three months for 24 months.

Primary Outcome Measure

Percentage of Subjects Converting to Exudative AMD at 24 Months. [ Time Frame: 24 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
NJ RetinaEdisonNew Jersey08817-
Retina Consultants of HoustonHoustonTexas77030-

Find similar trials in Beverly Hills, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CAOphthalmic Consultants of Boston· Boston, MANJ Retina· Edison, NJRetina Consultants of Houston· Houston, TX

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