Randomized Trial of Treat and Extend Ranibizumab With and Without Navigated Laser Versus Monthly Dosing for Diabetic Macular Edema: TREX-DME 2-Year Outcomes.

Abstract

PURPOSE:

To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema.

DESIGN:

This was a multicenter, randomized, clinical trial.

METHODS:

One hundred fifty eyes were randomized into 3 cohorts: monthly (n = 30), treat and extend without laser photocoagulation (TREX; n = 60), and treat and extend with angiography-guided laser photocoagulation (GILA; n = 60). Monthly cohort eyes received ranibizumab 0.3 mg every 4 weeks. TREX and GILA cohort eyes received 4 monthly injections of ranibizumab 0.3 mg followed by a treat and extend dosing strategy. GILA cohort eyes also received navigated focal laser at month 1 and again every 3 months as needed. The primary outcomes included the mean change in best-corrected visual acuity and central retinal thickness and the number of injections from baseline to 2 years.

RESULTS:

At 2 years, mean best-corrected visual acuity and central retinal thickness improved by 7.5, 9.6, and 9.0 letters (P = .75) and 139, 140, and 175 μm (P = .09), in the monthly, TREX, and GILA cohorts, respectively. The mean number of injections was significantly reduced in both the TREX (18.9) and GILA (17.5) cohorts compared with the monthly cohort (24.7, P < .001). Between the TREX and GILA cohorts, there was no significant difference in the mean treatment interval, mean maximal treatment interval, or percentage of eyes extended to 12 weeks. The total 2-year incidence of Anti-Platelet Trialists' Collaboration events was 6.7%.

CONCLUSION:

The treat and extend algorithm of ranibizumab in the TREX-DME trial resulted in significantly fewer injections and yielded visual and anatomic gains comparable to monthly dosing at 2 years.

• Authors: John F Payne, Charles C Wykoff, W Lloyd Clark, Beau B Bruce, David S Boyer, David M Brown, TREX-DME Study Group
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 202 Pg. 91-99 (06 2019) ISSN: 1879-1891 [Electronic] United States
• PMID: 30771333 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Vascular Endothelial Growth Factor A
• Ranibizumab

Topics

• Aged
• Algorithms
• Angiogenesis Inhibitors (administration & dosage)
• Diabetic Retinopathy (complications, diagnosis, therapy)
• Female
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Laser Coagulation (methods)
• Macular Edema (diagnosis, etiology, therapy)
• Male
• Middle Aged
• Prospective Studies
• Ranibizumab (administration & dosage)
• Time Factors
• Tomography, Optical Coherence (methods)
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity