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 GTC0182
Trial ID NCT01940887
Disease Age-Related Macular Degeneration
Altered gene PDGFB
Therapeutic/Target gene Target gene
TherapyAptamer
Treatment E10030|Fovista|anti-PDGF BB
Co-treatment Bevacizumab|Aflibercept
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|Austria|Brazil|Canada|Colombia|Croatia|Czechia|Estonia|Finland|France|Germany|Hungary|Israel|Italy|Latvia|Norway|Poland|Portugal|Slovakia|Spain|United States
Company sponsorOphthotech Corporation
Other ID(s)OPH1004

Clinical Result

Cohort 1
Administration route intravitreal injection
Dosage 1.5 mg
Pts 322
Age Adult, Older_Adult
Outcome The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning. Mean (Standard Error) = 9.42(0.85)
Adverse reactions 7/322(All-cause mortality); 58/322(Blood and lymphatic system disorders; Cardiac disorders; Eye disorders; Gastrointestinal disorders; General 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; Psychiatric disorders; Renal and urinary disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders)

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