Basic Information

Gene symbol PDGFB Synonyms IBGC5, PDGF-2, PDGF2, SIS, SSV, c-sis Type of gene protein-coding
Description platelet derived growth factor subunit B

GTO ID GTC0183
Trial ID NCT01940900
Disease Age-Related Macular Degeneration
Altered gene PDGFB
Therapeutic/Target gene Target gene
TherapyAptamer
Treatment E10030|Fovista|anti-PDGF BB
Co-treatment ranibizumab
PhasePhase3
Recruitment statusTerminated
TitleA Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin or Eylea Compared to Avastin or Eylea Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Year2013
CountryArgentina|Australia|Colombia|Denmark|France|Germany|Hungary|Israel|Spain|Turkey|United States
Company sponsorOphthotech Corporation
Other ID(s)OPH1003

Clinical Result

Cohort 1
Administration route intravitreal injection
Dosage 1.5 mg
Pts 312
Age Adult, Older_Adult
Outcome The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning. Mean (Standard Error) = 9.91(0.88)
Adverse reactions 4/312(All-cause mortality); 56/312(Cardiac disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General 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; Nervous system disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

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