Phase 3
Completed N=60
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
Macular Degeneration
Source: ClinicalTrials.gov NCT01748292 ↗
Enrolled (actual)
60
Serious AEs
50.0%
Results posted
Oct 2017
Primary outcomePrimary: Mean Change in BCVA by ETDRS Letter Score From Baseline — 10.5; 7.3; 9.2; 10.5 ETDRS BCVA Letters
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in BCVA by ETDRS Letter Score From Baseline |
10.5; 7.3; 9.2; 10.5; 10.4; 9.0 | — |
| SECONDARY Incidence and Severity of Adverse Events (Ocular and Non-ocular) |
2; 6; 7; 20 | — |
| SECONDARY Total Number of Intravitreal Injections Required |
13.0; 10.1; 25.5; 18.6; 31.5; 25 | — |
| SECONDARY Total Number of Office Visits and Imaging Studies Performed During Study Period |
262; 364; 560; 838; 801; 1143 | — |
| SECONDARY Percentage of Subjects With Persistent Active Exudation on SD-OCT |
3; 9; 5; 9; 9; 8 | — |
| SECONDARY Mean Change in Central Foveal Thickness |
-246; -173; -170; -170; -188; -183 | — |
| SECONDARY Percentage of Patients With Persistent Leakage on Fluorescein Angiography |
— | — |
| SECONDARY CNVM Lesion Size |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01748292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.