Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy (RIVAL Trial)

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Southeast Retina Center, Georgia
Study ID
NCT02092532
Phase
PHASE4
Status
Unknown

Conditions

  • Neovascular Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Rescue Intravitreal Aflibercept Injection — DRUG
    Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met.
  • Rescue Therapy with PDT, Laser or Intravitreal Steroids — PROCEDURE
    Starting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met.

Study Details

The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.

Key Dates

Start date
Mar 31, 2014
Status verified
Oct 2014
Primary completion
Mar 31, 2015
Completion
Mar 31, 2016

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Intravitreal Aflibercept Injection
    All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months.

Primary Outcome Measure

Incidence and Severity [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southeast Retina Center, PCAugustaGeorgia30909
Dennis M Marcus, MD
[email protected]
706-650-0061
Jared Gardner, BS
[email protected]
706-650-0061
Dennis M Marcus, MD (PRINCIPAL_INVESTIGATOR)
Harinderjit Singh, MD (SUB_INVESTIGATOR)

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By research site
Southeast Retina Center, PC· Augusta, GA