Yishen Yanggan Mingmu formula combined with anti-vascular endothelial growth factor drugs for the treatment of wet age-related macular degeneration

Not reported | Not specified | Gao J et al. (2023)

Gao J, Li M, Wang YY, Liao YH, Gong Y. Yishen Yanggan Mingmu formula combined with anti-vascular endothelial growth factor drugs for the treatment of wet age-related macular degeneration. Int J Ophthalmol, 2023; 23(8):1362-1366.

Locations

China

Study Period

September 2020 – November 2022

Study Design

Randomized, controlled, parallel-group clinical trial

Study Population

Characteristic:

Type of AMD:

2 (Wet AMD)

AMD Stage:

3 (Late)

Total Sample Size:

58 patients (58 eyes)

Age:

Randomized, controlled, parallel-group clinical trial

Sex (Male) n%:

Injection group: 19 (65.5%); Combination group: 14 (48.3%)

Experimental Group

Intervention Therapy:

Intravitreal conbercept 0.5 mg + oral Yishen Yanggan Mingmu formula

Dose & Frequency:

Intravitreal conbercept injection every 4 weeks (3 doses) + daily oral formula

Age (Years):

70.38 ± 10.18

Number of Patients:

29 randomized and treated

Male N %:

14 (48.3%)

Patients Followed Up:

Control Group

Intervention Therapy:

Intravitreal conbercept 0.5 mg alone

Dose & Frequency:

Intravitreal conbercept injection every 4 weeks (3 doses)

Age (Years):

70.24 ± 6.83

Number of Patients:

29 randomized and treated

Male N %:

19 (65.5%)

Patients Followed Up:

Follow-up Time: 3 months

Outcomes

Durability

Not reported

Vision

Best-Corrected Visual Acuity (BCVA) The mean change in BCVA from baseline to Month 3 (Primary Outcome):
• Injection group: -0.23 ± 0.30 logMAR
• Combination group: -0.32 ± 0.37 logMAR
• Difference: p= 0.331

Other

Total Effective Rate
The total effective rate at Month 3:
• Injection group: 66% (19/29)
• Combination group: 76% (22/29)
• Difference: p= 0.282

Others
• After 3 months of treatment, each kind of traditional Chinese medicine (TCM) syndrome in the combination group was significantly improved compared with those syndromes before the treatment (p<0.001).
• After the treatment, the scores of dizziness and insomnia, soreness and weakness of the waist and knees, paleness and cold limbs, dry eyes, and fatigue in the combination group were significantly lower than the injection group (p<0.001).

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Central Macular Thickness (CMT) The mean change in CMT from baseline to Month 3:
• Injection group: -95.36 ± 56.81 µm
• Combination group: -155.93 ± 143.79 µm
• Difference: p= 0.042.

Safety

Treatment-emergent AEs No significant safety concerns were reported.
Ocular-related AEs None reported.
Non-ocular AEs None reported.

Outcomes

Conclusion

The addition of Yishen Yanggan Mingmu formula to conbercept therapy resulted in greater improvement in CMT and overall treatment efficacy, but did not significantly impact BCVA at 3 months. Further research is needed to confirm long-term benefits.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns

Note: No information on the method of randomization or allocation concealment. However, the two groups were comparable at the baseline.

Missing Outcome Data

Low risk

Note: No missingness was reported. The analysis was based on all included patients.

Selection of the Reported Results

Some Concerns Note: The protocol is not publicly available.

Deviations from Intended Observations

Some concerns Note: This is an open-label study. No information on whether deviations arose because of the trial context. The analysis is based on all included patients.

Measurement of the Outcome

Low risk Note: This is an open-label study. However, the primary outcome assessment was unlikely to have been influenced by knowledge of intervention.

Overall

High risk