One-year outcomes of resveratrol supplement with aflibercept versus aflibercept monotherapy in wet age-related macular degeneration

Not reported | Not specified | Datseris I et al. (2023)

Datseris I, Bouratzis N, Kotronis C, Datseris I, Tzanidaki ME, Rouvas A, Gouliopoulos N. One-year outcomes of resveratrol supplement with aflibercept versus aflibercept monotherapy in wet age-related macular degeneration. Int J Ophthalmol, 2023; 16(9):1496-1502.

Locations

Conducted in Greece

Study Period

Not specified (the protocol was approved in January 2021)

Study Design

Prospective, randomized, monocentric, comparative study

Study Population

Characteristic:

Type of AMD:

2 (Wet AMD)

AMD Stage:

3 (Late)

Total Sample Size:

50 patients (25 in each group)

Age:

Prospective, randomized, monocentric, comparative study

Sex (Male) n%:

Resveratrol + aflibercept: 10 (40%); Aflibercept alone: 7 (28%)

Experimental Group

Intervention Therapy:

Intravitreal aflibercept 2.0 mg + daily oral Resvega® supplement

Dose & Frequency:

3 monthly intravitreal injections (2.0 mg aflibercept), followed by PRN injections; Resvega® taken daily

Age (Years):

74.44 ± 5.00

Number of Patients:

25 randomized and treated

Male N %:

10 (40%)

Patients Followed Up:

Control Group

Intervention Therapy:

Intravitreal aflibercept 2.0 mg monotherapy

Dose & Frequency:

3 monthly intravitreal injections (2.0 mg aflibercept), followed by PRN injections

Age (Years):

74.88 ± 7.58

Number of Patients:

25 randomized and treated

Male N %:

7 (28%)

Patients Followed Up:

Follow-up Time: 12 months

Outcomes

Durability

Number of Injections Number of aflibercept injections over 12 months:
• Resveratrol + aflibercept: 4.28 ± 0.90
• Aflibercept alone: 4.52 ± 1.00
• Difference: p=0.38.

Vision

Best-Corrected Visual Acuity (BCVA)
The mean change in BCVA from baseline at Month 12 (Primary Outcome):
• Resveratrol + aflibercept: 0.42 ± 0.23 logMAR
• Aflibercept alone: 0.53 ± 0.30 logMAR
• Difference: p= 0.12
Contrast Sensitivity
Contrast sensitivity at 12 months:
• Resveratrol + aflibercept: 1.21 ± 0.37
• Aflibercept alone: 1.04 ± 0.52
• Difference: p= 0.19

Other

Quality of Life (QoL) Depression HADS Depression score at 12 months:
• Resveratrol + aflibercept: 8.28 ± 1.54
• Aflibercept alone: 11.88 ± 2.51
• Difference: p <0.001.
Anxiety HADS Anxiety score at 12 months:
• Resveratrol + aflibercept: 7.76 ± 1.51
• Aflibercept alone: 11.92 ± 2.52
• Difference: p<0.001

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Safety

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

Outcomes

Conclusion

The addition of resveratrol (Resvega®) to aflibercept therapy improved contrast sensitivity and reduced depression and anxiety symptoms but did not significantly impact BCVA or the number of injections required over 12 months.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns

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

Missing Outcome Data

Low risk

Note: No patients withdrew.

Selection of the Reported Results

Some concerns Note: the protocol is not publicly available.

Deviations from Intended Observations

Some concerns Note: No information on whether deviations arose because of the trial context. No missingness for all patients. The ITT principle was applied for the data analysis.

Measurement of the Outcome

Some concerns Note: This is a single-center study. However, there is no information on the method of assessor masking.

Overall

High risk