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 GTC0184
Trial ID NCT01944839
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
CountryAustria|Belgium|Brazil|Canada|Czechia|Estonia|Italy|Latvia|Poland|Slovakia|Switzerland|United Kingdom|United States
Company sponsorOphthotech Corporation
Other ID(s)OPH1002

Clinical Result

Cohort 1
Administration route intravitreal injection
Dosage 1.5 mg
Pts 310
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) = 10.74(0.86)
Adverse reactions 6/310(All-cause mortality); 48/310(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; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders)

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