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A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512945-18-00
Acronym
APL2-GA-305
Enrollment
206
Registered
2024-09-16
Start date
2021-11-30
Completion date
2025-06-05
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy Secondary to Age-Related Macular Degeneration

Brief summary

Incidence and severity of ocular and systemic Aes

Detailed description

1.The total area of GA lesion(s) in the study eye (in mm2) as assessed by fundus autofluorescence (FAF), 2.The rate of GA lesion growth in the study eye as assessed by fundus autofluorescence (FAF), 3.NL-BCVA score (study eye) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart, 4. LL-BCVA score (study eye) as assessed by ETDRS chart, 5. Monocular maximum reading speed (study eye) corrected for number of words read incorrectly as assessed by Minnesota Reading (MNRead) charts or Radner charts, 6. Binocular maximum reading speed, corrected for number of words read incorrectly, as assessed by MNRead charts or Radner charts, 7.The number of absolute scotomatous points (study eye) assessed by mesopic microperimetry (selected participants [those who had the assessment performed in the antecedent study] only), 8. Macular sensitivity (study eye) as assessed by mesopic microperimetry (selected participants [those who had the assessment performed in the antecedent study] only), 9. Change in additional microperimetry parameters in the study eye (eg, 95% bivariate contour ellipse area [BCEA], number of points with a clinically significant decrease in mean sensitivity), 10.Mean FRI Index score, 11. NEI VFQ25 and NEI VFQ-39 (at select sites) composite score, near activity subscale score, distance activity subscale score, and NEI VFQ-25 driving subscale score

Interventions

DRUGAPL-2

Sponsors

Apellis Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence and severity of ocular and systemic Aes

Secondary

MeasureTime frame
1.The total area of GA lesion(s) in the study eye (in mm2) as assessed by fundus autofluorescence (FAF), 2.The rate of GA lesion growth in the study eye as assessed by fundus autofluorescence (FAF), 3.NL-BCVA score (study eye) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart, 4. LL-BCVA score (study eye) as assessed by ETDRS chart, 5. Monocular maximum reading speed (study eye) corrected for number of words read incorrectly as assessed by Minnesota Reading (MNRead) charts or Radner charts, 6. Binocular maximum reading speed, corrected for number of words read incorrectly, as assessed by MNRead charts or Radner charts, 7.The number of absolute scotomatous points (study eye) assessed by mesopic microperimetry (selected participants [those who had the assessment performed in the antecedent study] only), 8. Macular sensitivity (study eye) as assessed by mesopic microperimetry (selected participants [those who had the assessment performed in the antecedent study] only

Countries

Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026