Comparative dynamics of microperimetry parameters in patients with age-related macular degeneration treated with Retinalamin

Purpose. To compare the dynamics of functional parameters of the macular area in patients with dry and wet forms of age-related macular degeneration (AMD) during 24-month Retinalamin therapy using microperimetry (MP). Materials and methods. The study included 21 patients with intermediate dry AMD in one eye and wet AMD in the fellow eye. Patients were randomized into two groups: Group 1 (Retinalamin, n = 11, 22 eyes) and Group 2 (placebo, n = 10, 20 eyes). Microperimetry was performed using the MP-3 Nidek device (Japan) with the threshold macular program Macula 20_deg, testing 76 points within 2 to 20° from the fixation point, using a 0.43° stimulus (Goldmann III) of 200 ms duration and a 4–2 (fast) threshold strategy. The following parameters were analyzed: mean threshold retinal sensitivity (Ms, dB), fixation sensitivity (dB), presence of absolute and relative scotomas, and fixation stability. The follow-up period was 720 days (visits on days 90, 180, 270, 360, 450, 540, and 720). Results. In dry AMD, the Retinalamin group showed an increase in Ms of +3.27 ± 1.03 dB (p < 0.001), while the placebo group showed a decrease of –4.14 ± 2.11 dB (p = 0.002). In wet AMD, the Retinalamin group demonstrated a positive trend in Ms, but the increase was not statistically significant (p = 0.302), whereas the placebo group showed a decrease of –3.57 ± 0.94 dB (p = 0.002). The between-group difference in deltas reached 7.41 dB (d = 4.46, p < 0.001) in dry AMD and 5.57 dB (d = 3.93, p < 0.001) in wet AMD. The dynamics of fixation sensitivity in dry AMD largely mirrored those described for Ms. In the Retinalamin group, the increase was statistically significant at every visit starting from day 90 (all p < 0.001), indicating an early and stable effect. In dry AMD, fixation stability remained at 100 % in the Retinalamin group throughout the entire follow-up, with no eye showing loss of stable fixation. In the placebo group with dry AMD, stability decreased from 100 to 90 % by day 450. In wet AMD, the baseline level of stable fixation was lower (72.7 and 70.0 %); however, in the Retinalamin group, the proportion of eyes with stable fixation increased to 90.9 % by day 270, whereas in the placebo group it decreased to 50.0 %. The proportion of eyes without relative scotomas in the Retinalamin group increased from 27.3 to 100.0 % (p = 0.002) in dry AMD, and from 0.0 to 18.2 % in wet AMD; in the placebo group, relative scotomas were present in all eyes by day 180. Conclusion. Retinalamin therapy over 24 months provides a statistically significant increase in retinal sensitivity in dry AMD. All final deltas were positive and highly significant (p ≤ 0.002). In wet AMD, a trend toward improved mean retinal sensitivity was observed, and none of the patients receiving Retinalamin showed progression of the disease by the end of the follow-up period. The drug prevents the progression of functional defects, promotes regression of relative scotomas, and stabilizes fixation. In the placebo group, both forms showed progressive deterioration of both parameters (p < 0,05). These findings support the inclusion of Retinalamin in comprehensive AMD therapy with objective efficacy monitoring using MP.