Treat and 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
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: February 18, 2014
Last verified: February 2014
  Purpose

A treat and extend protocol starts with monthly injections until signs of activity have resolved with clinical and OCT confirmation. The interval between visits is then lengthened by 1 to 2 weeks as long as there are no signs of recurrent activity. Treatment is done at every visit but the time between visits is individualized based on a patient's response to treatment. When recurrent disease is detected, the treatment interval is reduced. The goal is to maintain an exudation-free macula with the fewest number of office visits, tests and injections.


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 Intravitreal Injections of 0.5mg Ranibizumab Given Monthly Compared to a Treat and 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: January 2016
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   50 Years and older
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
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
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: February 18, 2014
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

ClinicalTrials.gov processed this record on April 15, 2014