The MATE trial: a multicentre, mixed‑methodology, pilot, randomised controlled trial in neovascular age‑related macular degeneration
• IRAS: 178,790 • ISRCTN: 58,955,026 • EudraCT: 2015 002,302 36 | The MATE trial: a multicentre, mixed‑methodology, pilot, randomised controlled trial in neovascular age‑related macular degeneration | Airody et al. (2023)
Airody, A., Baseler, H. A., Seymour, J., Allgar, V., Mukherjee, R., Downey, L., Dhar‑Munshi, S., Mahmood, S., Balaskas, K., Empeslidis, T., Hanson, R. L. W., Dorey, T., Szczerbicki, T., Sivaprasad, S., & Gale, R. P. The MATE trial: a multicentre, mixed‑methodology, pilot, randomised controlled trial in neovascular age‑related macular degeneration. Pilot and Feasibility Studies 2023; 9:63. doi:10.1186/s40814-023-01288-0
Locations
Six NHS medical retina units across the UK
Study Period
December 2015 to January 2019
Study Design
Multicentre, pilot, mixed‑methodology, randomised controlled trial (RCT)
Study Population
Experimental Group
Control Group
Follow-up Time: 24 months
Outcomes
Durability
The mean number of treatments and visits from baseline to Month 12:
• SC group: 8.3 (SD = 0.7)
• T&E group: 17.3 (SD = 2)
The mean number of treatments and visits from baseline to Month 24:
• SC group: 9.5 (SD = 1.8)
• T&E group: 16.4 (SD = 3.8)
Vision
Best-corrected visual acuity (BCVA)
The mean change in BCVA from baseline to Month 12 (Primary Outcome):
• SC group: + 0.7 (SD 18.6) letters
• T&E group: + 5.7 (SD15.6) letters
The mean change in BCVA from baseline to Month 24:
• SC group: − 2.4 (SD 23.6) ETDRS letters
• T&E group: + 2.9 (SD 19.2) letters
Vision Maintaining
The gain of 15 ETDRS letters or more from baseline to Month 12:
• SC group: 3 out of 17 eyes (18%)
• T&E group 5 out of 18 eyes (28%)
The losing 15 letters or more from baseline to Month 24:
• SC group: 5 out of 17 (29%)
• T&E group: 3 out of 18 (17%)
Other
N/A
Immunognicity
Not reported
Pharmokinetics
Not reported
Anatomic
Central Retinal Thickness (CRT)
The mean change in CRT from baseline to Month 12:
• SC group: -116.5 µm (SD = 111.2 µm)
• T&E group: -147.8 µm (SD = 104 µm)
The mean change in CRT from baseline to Month 24:
• SC group: -148.8 µm (SD = 122.5 µm)
• T&E group: -164.8 µm (SD = 117.8 µm)
Safety
Adverse Events (AEs)
A total of 225 AEs were recorded across all sites (SC: 118 events; T&E: 107 events)
Serious Adverse Events (SAEs)
A total of 39 SAEs were recorded (SC: 23 events; T&E: 16 events)
Conclusion
The MATE trial met its predefined recruitment, non participation, and screen failure targets, demonstrating feasibility for a large scale RCT. The pilot data indicate that both standard care (SC) and treat and extend (T&E) regimens of aflibercept in nAMD yield similar trends in visual acuity and anatomical outcomes, supporting progression to a larger trial with minor protocol amendments.
Risk of Bias Assessment for Primary Outcome
Randomization Process
Low risk
Note: “A 1:1 randomization was performed allocating each participant into one of the treatment regimens. This service was provided by a web-based system and conducted centrally by the trial manager responsible for the whole trial.”
Baseline demographics of participants in the MATE trial in Table 1 look comparable.
Missing Outcome Data
Some concerns
Note: There is no evidence that the result was not biased by missing outcome data. However, as the missingness is balanced between the two groups, the missingness in the outcome is unlikely depending on its true value.
Selection of the Reported Results
Low risk Note: Registration with the protocol
Deviations from Intended Observations
Some concerns Note: This is an open labeled pilot study. There is no information on whether deviations from the intended intervention that arose because of the trial context. mITT principle was applied to eh primary efficacy outcome.
Measurement of the Outcome
Some concerns Note: “The optometrists performing visual acuity assessments were masked to the study participants’ allocation” As a multiple-site trial, no information on the consistency of the measurement.
Overall
High risk
Categories: Wet AMD