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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Charles C Wykoff, PhD, MD, Greater Houston Retina Research
ClinicalTrials.gov Identifier:
NCT01748292
First received: December 7, 2012
Last updated: March 11, 2015
Last verified: March 2015
  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: 0.5mg ranibizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Greater Houston Retina Research:

Primary Outcome Measures:
  • Mean change in ETDRS visual acuity From day 0 [ Time Frame: at 6 months (wk24-wk28), 12 months (wk48-wk57), 18 months (wk72-wk82) and 24 months (wk96-wk107) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events (ocular and non-ocular) [ Time Frame: at 6months to 24months ] [ Designated as safety issue: Yes ]
  • Total number of intravitreal injections required during 12 months (wk48-wk57) and 24-months (wk96-wk107) study period [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Total number of office visits and imaging studies performed during 12 months (wk48-wk57) and 24-months (wk96-wk107) study period [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Percentage of patients with persistent macular edema by SDOCT [ Time Frame: at 12 months (wk48-wk57) and 24-months (wk96-wk107) study period ] [ Designated as safety issue: No ]
  • Percentage of patients with persistent leakage on fluorescein angiography [ Time Frame: at 12 months (wk48-wk57) and 24-months (wk96-wk107) study period ] [ Designated as safety issue: No ]
  • CNVM lesion size [ Time Frame: at baseline, 12 months (wk48-wk57) and 24-months (wk96-wk107) study period as determined by fluorescein angiography ] [ Designated as safety issue: No ]
  • Mean change in central foveal thickness per SDOCT from randomization to 12 months (wk48-wk57) and randomization to 24-months (wk96-wk107) study period [ Time Frame: 12 months (wk48-wk57) and randomization to 24-months (wk96-wk107) study period ] [ Designated as safety issue: No ]
  • Percentage of patients gaining or losing 2 lines of vision or more and 1 line of vision or more [ Time Frame: at 6 months (wk24-wk28), 12 months (wk48-wk57), 18 months (wk72-wk82) and 24 months (wk96-wk107) from Day 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monthly 0.5mg intravitreal injection
Intravitreal injections monthly for 24 months, not less than 21 days apart to not more than 35 days apart
Drug: 0.5mg ranibizumab
The subject receives drug at every visit.
Other Name: Lucentis
Experimental: Treat and Extend
0.5mg 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 SDOCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)
Drug: 0.5mg ranibizumab
The subject receives drug at every visit.
Other Name: Lucentis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 
Study First Received: December 7, 2012
Last Updated: March 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on July 21, 2016