Effect of 2-year nutritional supplementation on progression of age-related macular degeneration

Not reported | GOAL in AMD Trial | Piatti A et al. (2020)

Piatti A, Croce A, Mazzacane D, et al. Effect of 2-year nutritional supplementation on progression of age-related macular degeneration. Eur J Ophthalmol, 2020; 30(2):376-381.

Locations

8 ophthalmology centers across Italy

Study Period

Not reported

Study Design

Multicenter, double-masked, placebo-controlled, randomized study

Study Population

Characteristic:

Type of AMD:

Dry AMD

AMD Stage:

2 (Intermediate)

Total Sample Size:

Age:

Multicenter, double-masked, placebo-controlled, randomized study

Sex (Male) n%:

23 (23/74, 31.8%)

Experimental Group

Intervention Therapy:

Nutritional supplement (Azyr Mega, SIFI S.p.A, Italy)

Dose & Frequency:

One tablet daily for 24 months, Composition Carotenoids (lutein 10 mg, astaxanthin 4 mg, zeaxanthin 2 mg), antioxidants (vitamin C 90 mg, vitamin E 30 mg, zinc 22.5 mg, copper 1 mg), omega-3 fatty acids (EPA 185 mg, DHA 140 mg).

Age (Years):

71.4 ± 6.5

Number of Patients:

48 randomized and treated

Male N %:

17 (35.4%)

Patients Followed Up:

48 (100%)

Control Group

Intervention Therapy:

Placebo (identical tablets without active ingredients)

Dose & Frequency:

One tablet daily for 24 months

Age (Years):

72.7 ± 5.5

Number of Patients:

26 randomized and treated

Male N %:

6 (23.1%)

Patients Followed Up:

26 (100%)

Follow-up Time: 24 months

Outcomes

Durability

Not reported

Vision

Best-Corrected Visual Acuity (BCVA) Mean change in BCVA (ETDRS letters) at 24 months:
• Supplement: Stable in 85.4%
• Placebo: Stable in 80.8%
• Difference: p = 0.74 Near VA Mean change in near VA (MNREAD chart) at 24 months:
• Supplement: Stable in 83.3%
• Placebo: Stable in 65.4%
• Difference: p = 0.08 Vision Maintaining The proportion of patients with worsening in all three measures (retinography, distance VA, and near VA):
• Supplement: 0%
• Placebo: 11.5%
• Difference: p = 0.04

Other

Efficacy: Progression outcomes AMD Progression AMD progression at 24 months (primary outcome):
• Supplement: 2.1% (1/48)
• Placebo: 15.4% (4/26)
• Difference: p = 0.049

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Not reported

Safety

During the entire study, no significant adverse events were recorded.

Outcomes

Conclusion

Nutritional supplementation with carotenoids, antioxidants, and omega-3 fatty acids significantly reduced the risk of AMD progression over 2 years compared to placebo. No safety concerns were noted.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns
Note: No information on the randomization and concealment method. However, the baseline is balanced between the two groups.

Missing Outcome Data

High risk
Note: A total of 6 patients (6/80, 7.5%) were excluded from the final analysis due to deviations from the protocol. The number of participants who were excluded from the analysis may have a substantial impact on the result.

Selection of the Reported Results

Some concerns Note: the protocol is not publicly available

Deviations from Intended Observations

Low risk Note: This is a double-masked study. mITT principle was applied

Measurement of the Outcome

Low risk Note: This is a double-masked study. “An independent reading center judged all the photographs taken during the clinical trial.”

Overall

High risk