The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT03022292
Phase
PHASE4
Status
Completed

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept Ophthalmic — DRUG
    IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC
  • optovue angiovue — DEVICE
    FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.

Study Details

A study investigating the ability of OCTA imaging technology to identify and analyze untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with exudative macular degeneration, as well as investigating the ability of the OCTA imaging technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in neovascular lesions associated with macular degeneration. This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed with neovascular AMD who are naive to previous Anti-VEGF therapies.

Key Dates

Start date
Mar 30, 2017
Status verified
Dec 2021
Primary completion
Jun 25, 2020
Completion
Aug 31, 2020

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: IAI Treatment
    Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Additional injections can be administered during the remaining visits on an as needed basis per Primary Investigator (PI) discretion based on the presence of any intraretinal or subretinal fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters, or evidence of either increased area, density, or activity of the brush border of the neovascularization on OCT-angiography. There will be a minimum of 21 days between subsequent injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum of 13 injections throughout the study period.

Primary Outcome Measure

Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. [ Time Frame: Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stein Eye Institute of UCLALos AngelesCalifornia90095-

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By research site
Stein Eye Institute of UCLA· Los Angeles, CA

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