Details

Autor(en) / Beteiligte

• Payne, John F.
• Wykoff, Charles C.
• Clark, W. Lloyd
• Bruce, Beau B.
• Boyer, David S.
• Brown, David M.
• Wells, John A.
• Johnson, David L.
• Benz, Matthew
• Chen, Eric
• Fish, Richard H.
• Kim, Rosa Y.
• Major, James C.
• O'Malley, Ronan E.
• Schefler, Amy C.
• Shah, Ankoor R.
• Wong, Tien P.
• Novack, Roger L.
• Chu, Thomas G.
• Rahhal, Firas
• Tabandeh, Homayoun
• Roe, Richard H.
• Dayani, Pouya N.
• Liao, David
• Walsh, Alexander
• Esmaili, Daniel D.

Titel

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

Ist Teil von

• American journal of ophthalmology, 2019-06, Vol.202, p.91-99

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2019

Quelle

MEDLINE

Beschreibungen/Notizen

• To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. This was a multicenter, randomized, clinical trial. 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. 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%. 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.