Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes.

Abstract

PURPOSE:

To compare monthly dosing with a treat and extend algorithm using ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation for center-involving diabetic macular edema (DME).

DESIGN:

Multicenter, prospective, randomized clinical trial.

PARTICIPANTS:

A total of 150 eyes from 116 subjects were randomized into 3 cohorts: Monthly (n = 30), TReat and EXtend without macular laser photocoagulation (TREX; n = 60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n = 60).

METHODS:

Monthly cohort eyes received ranibizumab 0.3 mg every 4 weeks. Eyes in the TREX and GILA cohorts received 4 monthly injections of ranibizumab 0.3 mg followed by a treat and extend algorithm based on disease activity. Eyes in the GILA cohort also received angiography-guided macular laser photocoagulation at month 1 and again every 3 months for microaneurysm leakage.

MAIN OUTCOME MEASURES:

Change in mean best-corrected visual acuity (BCVA), mean central retinal thickness (CRT), number of injections from baseline to 1 year, and percentage gaining/losing 2 and 3 lines of vision.

RESULTS:

Baseline demographics were well balanced among the cohorts. A total of 137 eyes (91%) completed the 1-year end point visit. At 1 year, the mean BCVA improved by 8.6, 9.6, and 9.5 letters in the Monthly, TREX, and GILA cohorts, respectively (P = 0.8). There was no significant difference between the cohorts in the percentage gaining/losing 2 and 3 lines of vision. The CRT improved by 123 μm, 146 μm, and 166 μm in the Monthly, TREX, and GILA cohorts, respectively (P = 0.47). The mean number of macular laser treatments in the GILA cohort at 1 year was 2.9 (range, 1-4). The number of injections was significantly reduced in both the TREX (10.7) and GILA (10.1) cohorts compared with the Monthly cohort (13.1, P < 0.001). There were no cases of endophthalmitis, and the total incidence of Anti-Platelet Trialists' Collaboration events was 4.7%.

CONCLUSIONS:

This prospective, randomized trial found that treat and extend dosing of ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation significantly decreased the number of injections given while providing similar visual and anatomic outcomes compared with monthly dosing at 1 year. Adding angiography-guided laser photocoagulation to this dosing algorithm did not significantly improve outcomes at 1 year.

• Authors: John F Payne, Charles C Wykoff, W Lloyd Clark, Beau B Bruce, David S Boyer, David M Brown, TREX-DME Study Group
• Journal: Ophthalmology (Ophthalmology) Vol. 124 Issue 1 Pg. 74-81 (01 2017) ISSN: 1549-4713 [Electronic] United States
• PMID: 27836430 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Ranibizumab

Topics

• Adult
• Aged
• Aged, 80 and over
• Algorithms
• Angiogenesis Inhibitors (therapeutic use)
• Combined Modality Therapy
• Diabetic Retinopathy (pathology, physiopathology, therapy)
• Female
• Humans
• Intravitreal Injections
• Laser Coagulation (methods)
• Macular Edema (pathology, physiopathology, therapy)
• Male
• Middle Aged
• Prospective Studies
• Ranibizumab (therapeutic use)
• Retina (pathology)
• Visual Acuity