Basic Information

Gene symbol C5 Synonyms C5D, C5a, C5b, CPAMD4, ECLZB Type of gene protein-coding
Description complement C5

GTO ID GTC0526
Trial ID NCT04435366
Disease Geographic Atrophy | Macular Degeneration
Altered gene C5
Therapeutic/Target gene Target gene
TherapyAptamer
Treatment Avacincaptad pegol|Zimura;ARC1905
PhasePhase3
Recruitment statusCompleted
TitleA Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Year2020
CountryArgentina|Australia|Austria|Belgium|Brazil|Canada|Colombia|Croatia|Czechia|Estonia|France|Germany|Hungary|Israel|Italy|Latvia|Poland|Spain|United Kingdom|United States
Company sponsorIVERIC bio, Inc.
Other ID(s)ISEE2008

Clinical Result

Cohort1: Avacincaptad Pegol
Administration route intravitreal injection
Dosage avacincaptad pegol, 2mg, Monthly through Month 11
Pts 225
Age Adult, Older_Adult
Outcome Mean Rate of Change in GA Over 12 Months (Measured at Three Time Points: Baseline, Month 6, and Month 12):Least Squares Mean (Standard Error):0.336(0.032)
Adverse reactions 2/225(All-cause mortality); 30/225(Cardiac disorders; Eye disorders; Gastrointestinal disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 37696275
Cohort2: sham administration
Administration route intravitreal injection
Dosage sham administration, Monthly through Month 11
Pts 222
Age Adult, Older_Adult
Outcome Mean Rate of Change in GA Over 12 Months (Measured at Three Time Points: Baseline, Month 6, and Month 12):Least Squares Mean (Standard Error):0.392(0.033)
Adverse reactions 1/222(All-cause mortality); 37/222(Cardiac disorders; Congenital, familial and genetic disorders; Eye disorders; Gastrointestinal disorders; Infections and infestations; Injury, poisoning and procedural complications; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Product Issues; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 37696275

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