Study for Recalcitrant Age Related Macular Degeneration

Part of paid clinical trials in Houston, Texas.

Sponsor
David M. Brown, M.D.
Study ID
NCT01543568
Phase
PHASE4
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.

Key Dates

Start date
Feb 29, 2012
Status verified
Nov 2016
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

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

Arms

  • Other: 2.0 mg intravitreal Aflibercept
    open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)

Primary Outcome Measure

The Number of Patients With no Fluid on OCT [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Consultants of HoustonHoustonTexas77030-

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