Can Oral Gildeuretinol Slow Advanced Macular Degeneration?

Although the trial missed its primary endpoint, exploratory analyses suggested slower lesion growth and better functional outcomes with gildeuretinol.

By
Andrea Surnit
July 20, 2026
3 min

MDSpire News

Objective:

To evaluate the efficacy of oral gildeuretinol acetate in slowing geographic atrophy progression in patients with age-related macular degeneration.

Approach:

Study Design: Phase 2/3 SAGA randomized clinical trial involving 198 patients aged 60 years or older with geographic atrophy secondary to age-related macular degeneration.
Intervention: Patients were assigned 2:1 to receive oral gildeuretinol acetate 14 mg once daily or placebo for 24 months.
Primary Endpoint: Geographic atrophy lesion growth measured by fundus autofluorescence.
Secondary Outcomes: Included low-luminance visual acuity (LLVA), best-corrected visual acuity (BCVA), VFQ-25, and FRI Index.

Key Findings:

Geographic atrophy lesion growth was reduced by 13% with gildeuretinol compared to placebo, but this difference was not statistically significant.
In a sensitivity analysis, lesion growth was reduced by 15% with gildeuretinol.
Patients on gildeuretinol experienced less decline in LLVA and better vision-related quality of life.
Safety findings were similar between treatment groups, with no new safety signals identified.

Interpretation:

The primary endpoint was not met, and secondary findings are considered exploratory.

Limitations:

Enrollment was curtailed to 198 participants instead of the planned 300 due to the COVID-19 pandemic, which reduced statistical power.
Approximately 70% of eyes contributed primary outcome data at 24 months.
Favorable findings from sensitivity analysis and secondary endpoints are hypothesis-generating.

Conclusion:

Oral gildeuretinol acetate did not show statistically significant benefit for the primary endpoint, but exploratory effects support further evaluation in larger trials.