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: August 6, 2014
Last verified: August 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
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
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: August 6, 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 September 18, 2014