Abstract | BACKGROUND: METHODS: RESULTS: The Miles assay model showed almost complete attenuation of VEGF-mediated vascular leakage following addition of EYE001, and the corneal angiogenesis model also showed a significant reduction in neovascularization with EYE001. The ROP model showed inhibition of 80% of the retinal neovascularization compared with controls (P = 0.0001). The phase IA safety study of patients with exudative AMD showed no significant safety issues related to the drug. Ophthalmic evaluation revealed that 80% of patients showed stable or improved vision 3 months after treatment and that 27% of eyes demonstrated a three-line or greater improvement in vision on the Early Treatment for Diabetic Retinopathy Study chart at this time. CONCLUSION: Anti- VEGF therapy is a promising new avenue for the treatment of neovascular diseases of the eye, including exudative macular degeneration and diabetic retinopathy. Preclinical data from studies with EYE001 support clinical evaluation of its efficacy in such diseases. This report is the first to describe administration of anti- VEGF therapy in humans for exudative macular degeneration and shows the safety of such therapy for single injections. Further clinical studies are necessary to determine the safety of multiple intravitreal injections of EYE001 and larger studies are needed to prove the efficacy of this novel, potentially therapeutic agent for neovascular AMD.
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Authors | Eyetech Study Group |
Journal | Retina (Philadelphia, Pa.)
(Retina)
Vol. 22
Issue 2
Pg. 143-52
(Apr 2002)
ISSN: 0275-004X [Print] United States |
PMID | 11927845
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Evaluation Study, Journal Article, Multicenter Study)
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Chemical References |
- Endothelial Growth Factors
- Lymphokines
- Oligonucleotides
- Vascular Endothelial Growth Factor A
- Vascular Endothelial Growth Factors
- NX1838
|
Topics |
- Aged
- Aged, 80 and over
- Animals
- Biological Availability
- Capillary Permeability
(drug effects)
- Choroidal Neovascularization
(drug therapy, etiology)
- Corneal Neovascularization
(chemically induced, drug therapy)
- Drug Evaluation, Preclinical
- Endothelial Growth Factors
- Exudates and Transudates
- Female
- Fluorescein Angiography
- Guinea Pigs
- Half-Life
- Humans
- Infant, Newborn
- Injections
- Lymphokines
- Macular Degeneration
(complications, drug therapy)
- Male
- Mice
- Mice, Nude
- Middle Aged
- Oligonucleotides
(administration & dosage, pharmacokinetics, therapeutic use)
- Rabbits
- Rats
- Retinal Neovascularization
(drug therapy)
- Retinopathy of Prematurity
(drug therapy)
- Skin
(blood supply)
- Skin Neoplasms
(drug therapy)
- Vascular Endothelial Growth Factor A
- Vascular Endothelial Growth Factors
- Vitreous Body
(metabolism)
|