Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab

Part of paid clinical trials in West Columbia, South Carolina.

Sponsor
Charles C Wykoff, PhD, MD
Study ID
NCT01748292
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 0.5 mg ranibizumab — DRUG
    Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit.

Study Details

TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm) respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN) treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a subject has achieved a "dry" macula; signs of active exudation have resolved will begin a Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is maintained). At the beginning of the 104-week endpoint subjects initially randomized to the TREX cohort will transition to PRN re-treatment when there is no exudative disease activity at the 12-week interval.

Key Dates

First listed
Dec 12, 2012
Start date
Dec 31, 2012
Status verified
May 2019
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

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

Arms

  • Active Comparator: Monthly IVT ranibizumab
    Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart
  • Experimental: Treat and Extend IVT ranibizumab
    0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)

Primary Outcome Measure

Mean Change in BCVA by ETDRS Letter Score From Baseline [ Time Frame: 6, 12, 18, 24, 30, and 36 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Retina Consultants of Houston/The Medical CenterHoustonTexas77030-
Retina Consultants of Houston/Katy officeKatyTexas77494-
Retina Consultants of HoustonThe WoodlandsTexas77384-

Find similar trials in West Columbia, SC

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Palmetto Retina Center· West Columbia, SCRetina Consultants of Houston/The Medical Center· Houston, TXRetina Consultants of Houston/Katy office· Katy, TXRetina Consultants of Houston· The Woodlands, TX

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