Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

Part of paid clinical trials in Peoria, Illinois.

Sponsor
Kamal Kishore, MD
Study ID
NCT02403128
Phase
PHASE1
Status
Unknown

Conditions

  • Macular Edema
  • Retinal Artery Macroaneurysm

Eligibility Criteria

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

Interventions

  • aflibercept — DRUG
    Intravitreal injection of 2.0 mg aflibercept at baseline, and repeated no sooner than two months from the previous injection for persistent macular edema as defined in the protocol.

Study Details

Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.

Key Dates

Start date
May 14, 2015
Status verified
Aug 2019
Primary completion
Feb 29, 2020
Completion
Feb 29, 2020

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with macular edema from RAM
    Intravitreal aflibercept 2.0 mg injection for eyes meeting eligibility criteria will be administered at baseline. Reinjection of the drug for protocol-defined criteria at least two months after previous injection.

Primary Outcome Measure

Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept [ Time Frame: six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Illinois Retina and Eye AssociatesPeoriaIllinois61615-

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Illinois Retina and Eye Associates· Peoria, IL

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