A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study)

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

Sponsor
Vitreous -Retina- Macula Consultants of New York
Study ID
NCT01115556
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment. The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.

Key Dates

First listed
May 4, 2010
Start date
May 31, 2010
Status verified
May 2018
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lucentis 2.0 mg
    Lucentis 2.0 mg
  • Active Comparator: LUCENTIS 0.5 mg

Primary Outcome Measure

Mean Change in Visual Acuity (VA) From Baseline at Month 6 [ Time Frame: Baseline and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vitreous Retina Macula Consultants of New YorkNew YorkNew York10022-

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

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