Detail

Basic Information Clinical Results Relationship Graph

Gene symbol	VEGFA	Synonyms	L-VEGF, MVCD1, VEGF, VPF	Type of gene	protein-coding
Chromosome	6	Map location	6p21.1	dbXrefs
Gene perturbation-related omics dataset	PerturbAtlas \| PertOrg
Description	vascular endothelial growth factor A

GTO ID	GTC0050
Trial ID	NCT00605280
Disease	Diabetes Mellitus \| Macular Edema
Altered gene	VEGFA
Therapeutic/Target gene	Target gene
Therapy	Aptamer
Treatment	Macugen\|pegaptanib\|EYE001
Phase	Phase2\|Phase3
Recruitment status	Completed
Title	A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension
Year	2005
Country	Australia\|Austria\|Brazil\|Canada\|Colombia\|Czechia\|Denmark\|France\|Germany\|Greece\|India\|Italy\|Netherlands\|Portugal\|South Africa\|Switzerland\|United Kingdom\|United States
Company sponsor	Pfizer
Other ID(s)	A5751013\|EOP1013H

Cohort1: Pegaptanib_dose level 1_from baseline up to 2 years

Administration route	intravitreal injection
Dosage	Pegaptanib Sodium, 0.3 mg, every 6 weeks from baseline up to 2 years
Pts	174
Age	Adult, Older_Adult
Outcome	Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year:Measure Type: Number:49
Adverse reactions	42/174(Cardiac disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Renal and urinary disorders; Skin and subcutaneous tissue disorders; Vascular disorders)
References	PMID: 21896838

Cohort2: Pegaptanib_dose level 2

Administration route	intravitreal injection
Dosage	Pegaptanib Sodium, 0.03 mg, every 6 weeks, up to 2 years
Pts	22
Age	Adult, Older_Adult
Adverse reactions	4/22(Gastrointestinal disorders; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Renal and urinary disorders; Vascular disorders)
References	PMID: 21896838

Cohort3: Pegaptanib_dose level 3

Administration route	intravitreal injection
Dosage	Pegaptanib Sodium, 0.003 mg, every 6 weeks, up to 2 years
Pts	7
Age	Adult, Older_Adult
Adverse reactions	No serious clinical adverse events
References	PMID: 21896838

Cohort4: sham injection

Administration route	intravitreal injection
Dosage	sham injection, from baseline up to Year 2
Pts	143
Age	Adult, Older_Adult
Outcome	Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year:Measure Type: Number:25
Adverse reactions	35/143(Cardiac disorders; Eye disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Vascular disorders)
References	PMID: 21896838

Cohort5: Pegaptanib_dose level 1_Year 3

Administration route	intravitreal injection
Dosage	Pegaptanib Sodium, 0.3 mg (Year 3)
Pts	46
Age	Adult, Older_Adult
Adverse reactions	4/46(Eye disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders)
References	PMID: 21896838

Cohort6: sham injection_Pegaptanib

Administration route	intravitreal injection
Dosage	Pegaptanib Sodium, 0.3 mg, every 6 weeks for 1 year (Year 3)
Pts	54
Age	Adult, Older_Adult
Adverse reactions	6/54(Blood and lymphatic system disorders; Gastrointestinal disorders; Infections and infestations; Injury, poisoning and procedural complications; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References	PMID: 21896838

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