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 GTC0045
Trial ID NCT00569140
Disease Age-Related Macular Degeneration
Altered gene PDGFB
Therapeutic/Target gene Target gene
TherapyAptamer
Treatment E10030|Fovista|anti-PDGF BB
PhasePhase1
Recruitment statusCompleted
TitleA Phase 1, Single Ascending Dose Trial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Monotherapy and of E10030 Given in Combination With Lucentis0.5 Mg/Eye in Subjects With Neovascular Age-Related Macular Degeneration
Year2007
CountryUnited States
Company sponsorOphthotech Corporation
Other ID(s)OPH 1000

Clinical Result

Cohort1: dose level 1
Administration route intravitreal injection
Dosage 0.03 mg
Pts 6
Age Adult, Older_Adult
Outcome Mean VA(visual acuity) Change: +13.4; Mean CST(central subfield thickness) Change: -140.7; CNV(choroidal neovascularization) Regression: 88.6%
Adverse reactions 6/6(Foreign body sensation in eyes; Conjunctival hemorrhage; Myodesopsia; Punctate keratitis)
References PMID: 26499921
Cohort2: dose level 2
Administration route intravitreal injection
Dosage 0.3 mg
Pts 8
Age Adult, Older_Adult
Outcome Mean VA(visual acuity) Change: +19.8; Mean CST(central subfield thickness) Change: -183.3; CNV(choroidal neovascularization) Regression: 84.1%
Adverse reactions 5/8(Conjunctival hemorrhage; Eye irritation; Conjunctival edema)
References PMID: 26499921
Cohort3: dose level 3
Administration route intravitreal injection
Dosage 1.5 mg
Pts 5
Age Adult, Older_Adult
Outcome Mean VA(visual acuity) Change: +9.0; Mean CST(central subfield thickness) Change:-87.9; CNV(choroidal neovascularization) Regression: 94.4%
Adverse reactions 3/5(Eye irritation; Myodesopsia; Punctate keratitis)
References PMID: 26499921
Cohort4: dose level 4
Administration route intravitreal injection
Dosage 3 mg
Pts 4
Age Adult, Older_Adult
Outcome Mean VA(visual acuity) Change: +9.5; Mean CST(central subfield thickness) Change: -100.9; CNV(choroidal neovascularization) Regression: 75.3%
Adverse reactions 4/4(Foreign body sensation in eyes; Eye irritation; Myodesopsia; Macular degeneration)
References PMID: 26499921

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