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Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab (T-REX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748292
First Posted: December 12, 2012
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Charles C Wykoff, PhD, MD, Greater Houston Retina Research
  Purpose
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.

Condition Intervention Phase
Macular Degeneration Drug: 0.5 mg ranibizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb, Multicenter, Randomized, Controlled Study of the Safety, Tolerability and Efficacy of IVT 0.5mg Ranibizumab Monthly Compared to a Treat & Extend Protocol in Patients With Wet Age-related Macular Degeneration (T-REX)

Resource links provided by NLM:


Further study details as provided by Charles C Wykoff, PhD, MD, Greater Houston Retina Research:

Primary Outcome Measures:
  • Mean Change in BCVA by ETDRS Letter Score From Baseline [ Time Frame: 6, 12, 18, 24, 30, and 36 months ]
    Mean change in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline through weeks 24-28, baseline through weeks 48-56, baseline through weeks 72-82, baseline to week 104, baseline through weeks 128-132 and baseline to week 156. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. The scale ranges from 0 to 100 letters


Secondary Outcome Measures:
  • Incidence and Severity of Adverse Events (Ocular and Non-ocular) [ Time Frame: 36 months ]
    Incidence and severity of adverse events both ocular and non-ocular

  • Total Number of Intravitreal Injections Required [ Time Frame: 12, 24, and 36 months ]
    Total number of intravitreal injections required from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.

  • Total Number of Office Visits and Imaging Studies Performed During Study Period [ Time Frame: 6, 12, 18, 24, 30, and 36 months ]
    Total number of office visits and imaging studies performed from baseline through weeks 24-28 (week closest to week 26), baseline through weeks 48-56 (week closest to week 52), baseline through weeks 72-82 (week closest to week 78), baseline through week 104, baseline through weeks 128-132 (week closest to week 132) and baseline through week 156

  • Percentage of Subjects With Persistent Active Exudation on SD-OCT [ Time Frame: 12, 24, and 36 months ]
    Percentage of subjects with persistent active exudation on SD-OCT from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.

  • Percentage of Patients With Persistent Leakage on Fluorescein Angiography [ Time Frame: 6, 12, 18, 24, 30, and 36 months ]
    Percentage of subjects with persistent leakage on fluorescein angiography from baseline through weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128- 132 and baseline to week 156.

  • CNVM Lesion Size [ Time Frame: 6, 12, 18, 24, 30, and 36 months ]
    CNVM lesion size at baseline, compared to baseline to weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128-132 and baseline to week 156, as determined by fluorescein angiography.

  • Mean Change in Central Foveal Thickness [ Time Frame: 12, 24, and 36 months ]
    Mean change in central foveal thickness by SD-OCT from baseline to weeks 48-57, baseline to week 104 and baseline to week 156.


Enrollment: 60
Actual Study Start Date: December 2012
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 0.5 mg ranibizumab
Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit.
Other Name: Lucentis
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)
Drug: 0.5 mg ranibizumab
Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit.
Other Name: Lucentis

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 50 years
  • Ability and willingness to return for all scheduled visits and assessments
  • Any CNVM lesion (Occult, Minimally Classic or Classic) (i.e., leakage on fluorescein angiography or subretinal, intraretinal activity on SDOCT) secondary to age-related macular degeneration.

Best corrected visual acuity in the study eye, using ETDRS testing, between 20/32 and 20/400 (Snellen equivalent), inclusive.

-The total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the total lesion. Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging.

Exclusion Criteria:

  • Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm2) in size
  • Subfoveal fibrosis or atrophy in the study eye
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748292


Locations
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, Texas
Retina Consultants of Houston/The Medical Center
Houston, Texas, United States, 77030
Retina Consultants of Houston/Katy office
Katy, Texas, United States, 77494
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Charles C Wykoff, PhD, MD
Genentech, Inc.
Investigators
Principal Investigator: Charles C Wykoff, PhD, MD Retinal Consultants of Houston
  Study Documents (Full-Text)

Documents provided by Charles C Wykoff, PhD, MD, Greater Houston Retina Research:
Informed Consent Form  [PDF] August 8, 2017

  More Information

Publications:
Busbee BG, Yee W, Li Z, et al. Efficacy and safety of 2.0mg or 0.5mg ranibizumab in patients with subfoveal neovascular AMD: HARBOR Study. American Academy of Ophthalmology; Orlando, Florida October 24, 2011.

Responsible Party: Charles C Wykoff, PhD, MD, Deputy Director of Research, Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01748292     History of Changes
Other Study ID Numbers: ML28513
First Submitted: December 7, 2012
First Posted: December 12, 2012
Results First Submitted: August 8, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Charles C Wykoff, PhD, MD, Greater Houston Retina Research:
Age related
Macular
sub retinal fluid
Age related Macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents