Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Retina Research Institute, LLC
Study ID
NCT01578720
Phase
PHASE1
Status
Completed

Conditions

  • Choroidal Neovascularization
  • Presumed Ocular Histoplasmosis

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).

Key Dates

Start date
Jun 30, 2012
Status verified
Aug 2018
Primary completion
Apr 30, 2014
Completion
Mar 31, 2015

Study Design

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

Arms

  • Other: IVT injection once every 8 weeks after 3 initial monthly doses
    Intravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of greater than or equal to 5 letters from the previous visit.

Primary Outcome Measure

Safety [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
The Retina InstituteSt LouisMissouri63017-
The Retina InstituteSt LouisMissouri63128-
The Retina InstituteSt LouisMissouri63144-

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