PubMed:25322754 JSONTXT

{"project":"PubmedHPO","denotations":[{"id":"T1","span":{"begin":204,"end":215},"obj":"HP_0000488"},{"id":"T2","span":{"begin":224,"end":256},"obj":"HP_0007868"},{"id":"T3","span":{"begin":236,"end":256},"obj":"HP_0000608"},{"id":"T4","span":{"begin":438,"end":443},"obj":"HP_0000618"}],"text":"Angiogenic gene therapy does not cause retinal pathology.\nBACKGROUND: The potential negative influence of angiogenic gene therapy on the development or progression of retinal pathologies such as diabetic retinopathy (DR) or age-related macular degeneration (AMD) has led to the systematic exclusion of affected patients from trials. We investigated the role of nonviral fibroblast factor 1 (NV1FGF) in two phase II, multinational, double-blind, randomized, placebo-controlled, gene therapy trials (TALISMAN 201 and 211).\nMETHODS: One hundred and fifty-two subjects with critical limb ischemia or claudication were randomized to receive eight intramuscular injections of 2.5 ml of NV1FGF at 0.2 mg/ml or 0.4 mg/dl or placebo. One hundred and fifty-two patients received a plasmid dose of NV1FGF of up to 32 mg or placebo. All patients underwent a systematic ophthalmologic examination at baseline and at 3, 6 or 12 months following gene therapy. Twenty-six of these patients (Münster subgroup) received a retinal fluorescence angiography at baseline and at final examination.\nRESULTS: Among those 26 patients, four of nine patients with diabetes suffered from nonproliferative DR. Three patients showed non-exsudative AMD. No change of retinal morphology or function was observed in Münster subgroup of both TALISMAN trials independent of the intramuscular NV1FGF dosage applied.\nCONCLUSIONS: Angiogenic gene therapy using NV1FGF is safe even in diabetics."}

{"project":"Zierdiyeerkenaili_800_3","denotations":[{"id":"T1","span":{"begin":570,"end":592},"obj":"DP"},{"id":"T2","span":{"begin":596,"end":608},"obj":"DP"},{"id":"T3","span":{"begin":361,"end":389},"obj":"CI"},{"id":"T4","span":{"begin":391,"end":397},"obj":"CI"},{"id":"T5","span":{"begin":680,"end":686},"obj":"CI"},{"id":"T6","span":{"begin":787,"end":793},"obj":"CI"},{"id":"T7","span":{"begin":1356,"end":1362},"obj":"CI"},{"id":"T8","span":{"begin":1422,"end":1428},"obj":"CI"}],"text":"Angiogenic gene therapy does not cause retinal pathology.\nBACKGROUND: The potential negative influence of angiogenic gene therapy on the development or progression of retinal pathologies such as diabetic retinopathy (DR) or age-related macular degeneration (AMD) has led to the systematic exclusion of affected patients from trials. We investigated the role of nonviral fibroblast factor 1 (NV1FGF) in two phase II, multinational, double-blind, randomized, placebo-controlled, gene therapy trials (TALISMAN 201 and 211).\nMETHODS: One hundred and fifty-two subjects with critical limb ischemia or claudication were randomized to receive eight intramuscular injections of 2.5 ml of NV1FGF at 0.2 mg/ml or 0.4 mg/dl or placebo. One hundred and fifty-two patients received a plasmid dose of NV1FGF of up to 32 mg or placebo. All patients underwent a systematic ophthalmologic examination at baseline and at 3, 6 or 12 months following gene therapy. Twenty-six of these patients (Münster subgroup) received a retinal fluorescence angiography at baseline and at final examination.\nRESULTS: Among those 26 patients, four of nine patients with diabetes suffered from nonproliferative DR. Three patients showed non-exsudative AMD. No change of retinal morphology or function was observed in Münster subgroup of both TALISMAN trials independent of the intramuscular NV1FGF dosage applied.\nCONCLUSIONS: Angiogenic gene therapy using NV1FGF is safe even in diabetics."}

{"project":"yaoziqian_800_3","denotations":[{"id":"T1","span":{"begin":361,"end":389},"obj":"CI"},{"id":"T2","span":{"begin":680,"end":686},"obj":"CI"},{"id":"T3","span":{"begin":787,"end":793},"obj":"CI"},{"id":"T4","span":{"begin":1422,"end":1428},"obj":"CI"},{"id":"T5","span":{"begin":1356,"end":1362},"obj":"CI"},{"id":"T6","span":{"begin":391,"end":397},"obj":"CI"},{"id":"T7","span":{"begin":570,"end":592},"obj":"DP"},{"id":"T8","span":{"begin":596,"end":608},"obj":"DP"}],"text":"Angiogenic gene therapy does not cause retinal pathology.\nBACKGROUND: The potential negative influence of angiogenic gene therapy on the development or progression of retinal pathologies such as diabetic retinopathy (DR) or age-related macular degeneration (AMD) has led to the systematic exclusion of affected patients from trials. We investigated the role of nonviral fibroblast factor 1 (NV1FGF) in two phase II, multinational, double-blind, randomized, placebo-controlled, gene therapy trials (TALISMAN 201 and 211).\nMETHODS: One hundred and fifty-two subjects with critical limb ischemia or claudication were randomized to receive eight intramuscular injections of 2.5 ml of NV1FGF at 0.2 mg/ml or 0.4 mg/dl or placebo. One hundred and fifty-two patients received a plasmid dose of NV1FGF of up to 32 mg or placebo. All patients underwent a systematic ophthalmologic examination at baseline and at 3, 6 or 12 months following gene therapy. Twenty-six of these patients (Münster subgroup) received a retinal fluorescence angiography at baseline and at final examination.\nRESULTS: Among those 26 patients, four of nine patients with diabetes suffered from nonproliferative DR. Three patients showed non-exsudative AMD. No change of retinal morphology or function was observed in Münster subgroup of both TALISMAN trials independent of the intramuscular NV1FGF dosage applied.\nCONCLUSIONS: Angiogenic gene therapy using NV1FGF is safe even in diabetics."}