Intense Treatment Regimen With Intravitreal Aflibercept Injection

Part of paid clinical trials in New York, New York.

Sponsor
Vitreous -Retina- Macula Consultants of New York
Study ID
NCT03594461
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept Injection — DRUG
    Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy

Study Details

This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks

Key Dates

Start date
Sep 11, 2018
Status verified
Jan 2019
Primary completion
Mar 31, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2mg IAI q2w
    2mg Intravitreal Aflibercept injection will be given every 2 weeks starting at baseline and then at weeks 2, 4, 6, 8, 10 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.
  • Experimental: 2mg IAI q3w
    2mg Intravitreal Aflibercept injection will be given every 3 weeks starting at baseline and then at weeks 3, 6, 9 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.

Primary Outcome Measure

Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy [ Time Frame: Baseline to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vitreous Retina Macula Consultants of New YorkNew YorkNew York10022
Peggy Guerrero
212-452-6965
K.Bailey Freund, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Vitreous Retina Macula Consultants of New York· New York, NY

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