A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)

Part of paid clinical trials in Houston, Texas.

Sponsor
David M. Brown, M.D.
Study ID
NCT01025232
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Age Related Macular Degeneration
  • Choroidal Neovascular Membrane
  • Macular Degeneration
  • Subfoveal Neovascular Age-Related Macular Degeneration
  • Wet Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intravitreal Injection of 2.0mg formulation

Study Details

The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.

Key Dates

First listed
Dec 3, 2009
Start date
Dec 31, 2009
Status verified
Nov 2016
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

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

Arms

  • Active Comparator: 4 Week Re-treatment
    Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
  • Active Comparator: 6 Week Re-treatment
    Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.

Primary Outcome Measure

Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.) [ Time Frame: 1 Year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Greater Houston Retina ResearchHoustonTexas77030-
Greater Houston Retina ResearchThe WoodlandsTexas77384-

Find similar trials in Houston, TX

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Greater Houston Retina Research· Houston, TXGreater Houston Retina Research· The Woodlands, TX

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