Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · May 19, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed, informed consent.
• • 2. Men and women greater than or equal to 55 years of age.
• • 3. Recent development of RPED secondary to AMD.
• • 4. ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
• • 5. Willing and committed and able to return for all clinic visits and complete all study related procedures.
• Exclusion Criteria:
• • 1. Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
• • 2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
• • 3. Total lesion size greater than 12 disc areas.
• • 4. Subretinal hemorrhage that is either 50% or more of the total lesion area or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.
• • 5. Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
• • 6. Scar, fibrosis or atrophy involving the center of the fovea.
• • 7. Presence of a retinal pigment epithelial tear.
• • 8. History of a vitreous hemorrhage within 4 weeks prior to initiation of the study.
• • 9. Presence of other causes of choroidal neovascular membrane other than AMD.
• • 10. History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes
• • 11. Prior vitrectomy surgery in the study eye.
• • 12. History of retinal detachment treatment in the study eye.
• • 13. History of macular hole in the study eye.
• • 14. Any intraocular/periocular surgery within 3 months of the initiation of the study.
• • 15. Prior trabeculectomy or filtering surgery in the study eye.
• • 16. Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment.
• • 17. Active intraocular inflammation.
• • 18. Active ocular/periocular infection.
• • 19. Any history of uveitis.
• • 20. Active scleritis or episcleritis.
• • 21. Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye.
• • 22. Previous radiation therapy in the region of the study eye.
• • 23. History of corneal transplant or corneal dystrophy in the study eye.
• • 24. Significant medial opacities including cataract that may interfere with visual acuity or fundus photography.
• • 25. Any disease or ocular condition which, in the opinion of the investigator could either increase in the risk to the subject beyond what is expected from a standard procedure of intraocular injections or which may be considered contraindicated for the use of the investigational drug (VEGF Trap).
• • 26. The use of long acting steroids systemically or intraocularly.
• • 27. Any history of allergy to Proviodine or fluorescein sodium.