Background/Aims Prospectively evaluate outcomes in the third year of neovascular age-related macular degeneration (AMD) management using ranibizumab with continued treat and extend (TREX) dosing compared with monthly visits with retreatment upon evidence of exudative disease activity (PRN, pro re nata).
Methods Subjects with treatment-naïve neovascular AMD were randomised 1:2 to Monthly or TREX and managed through 2 years. In the third year, subjects randomised to Monthly were managed PRN while subjects randomised to TREX were continued on TREX dosing or transitioned to PRN after achieving an interval of 12 weeks between visits.
Results Sixty subjects enrolled and 46 (77%) completed month 36 (M36). Transition from Monthly to PRN was associated with a decline in best corrected visual acuity (BCVA) (+10.5 letters (month 24) to +5.4 (M36, p=0.09)); three (15%) subjects required no dosing during year 3, and 47% (114/243) of possible PRN injections were delivered, yielding a mean of 6.1 injections during year 3. Among the 9 (23%) TREX subjects transitioned to PRN, the need for ongoing anti-vascular endothelial growth factor retreatments was small, with 4 (4%) intravitreal injections being delivered among 106 PRN visits; this subgroup displayed an inferior BCVA trajectory compared with the remainder of subjects. Outcomes among subjects continued on TREX were more favourable, with a mean gain of +5.0 letters at M36.
Conclusions Upon transition to PRN, subjects randomised to monthly dosing experienced a decline in BCVA. Among subjects initially randomised to TREX who transitioned to PRN after achieving a 12-week interval between visits, the overall need for additional treatment was low.
Trial registration number NCT01748292, Results.
- clinical trial
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Contributors Research design: CCW, DEC, DMB. Data acquisition and/or research execution: CCW, WCO, DEC, JFP, DMB, WLC. Data analysis and/or interpretation: CCW, WCO, DEC, NSA, SRS. Manuscript preparation: CCW, WCO, DEC, JFP, DMB, WLC, NSA, SRS.
Funding Research grant from Genentech, Inc., South San Francisco, CA. The funding organisation had no role in the design or conduct of this research.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: financial support for the submitted work from Genentech, Inc., South San Francisco, CA; CCW reports grants and personal fees from Alcon, grants from Allegro, grants and personal fees from Allergan, grants from Apellis, grants from Aura, grants and personal fees from Clearside, grants and personal fees from Genentech, grants and personal fees from Iconic Therapeutics, grants from NEI, grants from NIH, grants from Novartis, grants from OHR Pharmaceuticals, grants from Ophthotech, grants from pSivida, grants and personal fees from Regeneron, grants from Roche, grants from Santen, grants from SciFluor, grants from Tyrogenex, personal fees from Alimera Sciences, personal fees from Alnylam Pharmaceuticals, personal fees from Bayer, personal fees from DORC, personal fees from ONL Therapeutics, personal fees from Thrombogenics and personal fees from Valeant. JFP reports grants from Genentech, grants from Regeneron, grants from Alcon, grants from EMMES, grants from Bayer, personal fees from Adverum, grants and personal fees from Allergan, grants and personal fees from DRCR Network. DMB reports grants and personal fees from Regeneron, personal fees from Regenxbio, grants from Clearside Biomedical, grants and personal fees from OHR, personal fees from Bayer, personal fees from Heidelberg, grants and personal fees from Novartis, personal fees from Optos, personal fees from Zeiss, grants and personal fees from Thrombogenics, grants from Ophthotech, grants from NEI. WLC reports grants and personal fees from Genentech/Roche, grants and personal fees from Ohr Pharmaceuticals, grants from Allergan, grants from Aerpio, grants, personal fees and non-financial support from Regeneron Pharmaceuticals. SRS reports other from Topcon, grants and personal fees from Carl Zeiss, grants and personal fees from Optos, personal fees from Allergan, personal fees from Iconic Therapeutics, personal fees from Novartis, personal fees from Thrombogenics, grants and personal fees from Genentech. No other relationships or activities could appear to have influenced the submitted work.
Ethics approval Sterling Institutional Review Board, Atlanta, GA.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Members of the TREX-AMD Study Group: CCW, WCO, DEC, JFP, DMB, WLC, NSA, SRS, Matthew S Benz, Eric Chen, Richard H Fish, Christopher R Henry, David L Johnson, Rosa Y Kim, James C Major Jr., Ronan E O’Malley, Amy C Schefler, Ankoor R Shah, Rui Wang, John A Wells III, Tien P Wong