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Related Experiment Video

Updated: Apr 22, 2026

Limbal Approach-Subretinal Injection of Viral Vectors for Gene Therapy in Mice Retinal Pigment Epithelium
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Angiogenic gene therapy does not cause retinal pathology.

Verena Prokosch1, Tobias Stupp, Kristina Spaniol

  • 1University Eye Hospital of Münster, Münster, Germany.

The Journal of Gene Medicine
|October 18, 2014
PubMed
Summary

Nonviral fibroblast growth factor 1 (NV1FGF) gene therapy showed no negative effects on retinal health in patients with critical limb ischemia, including those with diabetes, suggesting safety for diabetic retinopathy patients.

Keywords:
age-related macular degenerationangiogenic gene therapydiabetic retinopathynonviral fibroblast factor 1

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Area of Science:

  • Ophthalmology
  • Gene Therapy
  • Vascular Biology

Background:

  • Patients with diabetic retinopathy (DR) and age-related macular degeneration (AMD) are often excluded from angiogenic gene therapy trials due to safety concerns.
  • The safety of nonviral fibroblast growth factor 1 (NV1FGF) gene therapy in these patient populations requires investigation.

Purpose of the Study:

  • To evaluate the safety and potential ocular effects of NV1FGF gene therapy in patients undergoing trials for critical limb ischemia.
  • To assess the impact of NV1FGF on retinal morphology and function in patients with and without diabetes.

Main Methods:

  • Two multinational, double-blind, randomized, placebo-controlled phase II trials (TALISMAN 201 and 211) involving 152 subjects with critical limb ischemia.
  • Systematic ophthalmologic examinations and retinal fluorescence angiography were performed at baseline and follow-up intervals (3, 6, or 12 months).
  • Analysis focused on a subgroup of 26 patients (Münster subgroup) who received retinal imaging.

Main Results:

  • Among the 26 patients in the Münster subgroup, four of nine diabetic patients had nonproliferative DR, and three had non-exudative AMD.
  • No changes in retinal morphology or function were observed in the Münster subgroup, irrespective of the NV1FGF dosage administered.

Conclusions:

  • Intramuscular NV1FGF angiogenic gene therapy is safe for patients with critical limb ischemia, even those with diabetes.
  • The findings support the potential safety of NV1FGF in patients with retinal vascular conditions like DR and AMD.