Mongolian Medicine Mingmu-11 Pills Combined with Conbercept in the Treatment of Wet Age-Related Macular Degeneration

Not reported | Not reported | Su R et al. (2024)

Su, R., Ran, L., Xiao, Q. Mongolian Medicine Mingmu-11 Pills Combined with Conbercept in the Treatment of Wet Age-Related Macular Degeneration. International Eye Science, 2024; 24(5):691-696.

Locations

Inner Mongolia, China

Study Period

November 2020 – December 2021

Study Design

Prospective, randomized, controlled trial

Study Population

Characteristic:

Type of AMD:

2 (Wet AMD)

AMD Stage:

3 (Late)

Total Sample Size:

72 patients (72 eyes) randomized into two groups (36 eyes per group)

Age:

Prospective, randomized, controlled trial

Sex (Male) n%:

Not reported

Experimental Group

Intervention Therapy:

Mingmu-11 Pills + Conbercept 0.05 mL

Dose & Frequency:

Conbercept injection once a month for 3 months + Mingmu-11 Pills twice daily (15 pills/dose) for 9 weeks (3 cycles)

Age (Years):

66.3±8.1

Number of Patients:

Male N %:

Not separately reported

Patients Followed Up:

Control Group

Intervention Therapy:

Conbercept 0.05 mL only

Dose & Frequency:

Conbercept injection once a month for 3 months

Age (Years):

65.7±6.9

Number of Patients:

Male N %:

Not separately reported

Patients Followed Up:

Follow-up Time: 5 months

Outcomes

Durability

Not reported

Vision

Best-Corrected Visual Acuity (BCVA)
Mean BCVA change at 3 months (Primary Outcome):
• Experimental = +17.42 ± 3.29 letters
• Control = +14.61 ± 3.14 letters
• Difference = +2.81 letters (p < 0.001).
Mean BCVA change at 5 months:
• Experimental = +19.75 ± 3.25 letters
• Control = +16.81 ± 2.77 letters
• Difference = +2.94 letters (p < 0.001).

Other

• The amplitude density of N1 and P1 waves in mfERG at 3 months after treatment was higher than that before treatment for both groups (p < 0.05).
• The r1-r3 latency of P1 wave was shorter than that before treatment (p < 0.05) with no differences in the r1- r3 latency of N1 wave (p > 0.05) for both groups.
• The amplitude density of the N1 and P1 wave in the combined treatment group was higher than that in the control group at 3 months after treatment (p < 0.05), and the latency of the P1 wave in the treatment group was significantly shorter than that in the control group (p < 0.05), and there was no significant difference in the latency of N1 wave between the two groups (p >0.05).

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Central Macular Thickness (CMT)
Mean CMT at 3 months:
• Experimental = 304.58 ± 53.34 µm
• Control = 351.94 ± 52.99 µm
• Difference = -47.36 µm (p < 0.001).
Mean CMT at 5 months:
• Experimental = 274.17 ± 62.26 µm
• Control = 321.78 ± 63.22 µm
• Difference = -47.61 µm (p < 0.05).

Safety

Not reported

Outcomes

Conclusion

Mingmu-11 Pills combined with Conbercept significantly improved BCVA and reduced macular edema compared to Conbercept alone in wAMD treatment.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns

Note: No information for allocation concealment and the method of the randomization. However, the baseline characteristics of the two groups were balanced.

Missing Outcome Data

Low risk

Note: No missingness.

Selection of the Reported Results

Some concerns Note: protocol is not publicly available.

Deviations from Intended Observations

Low risk Note: This an open-labeled study. However, no missingness or deviations were reported. All patients were completed the studies and included into the final analysis.

Measurement of the Outcome

Some concerns Note: No information on the blinding of the intervention to assessors. However, the assessment of the outcome unlikely have been influenced by knowledge of intervention received.

Overall

High risk