Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

Launched by OPHTHALMIC CONSULTANTS OF BOSTON · Nov 7, 2012

Keywords

ClinConnect Summary

Protocol available upon request.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Diagnosis of one or more of the following:
• • Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).
• • 2. Be in need of IAI treatment, whether previously treated or treatment-naïve.
• • 3. Age \> 18 years.
• Exclusion Criteria:
• • 1. Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
• • 2. Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
• • 3. Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
• • 4. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
• • 5. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
• • 6. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
• • 7. Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
• • 8. Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
• • 9. History of vitrectomy surgery in the study eye.
• • 10. Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
• • 11. Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
• • 12. Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
• • 13. Pregnant or breast-feeding women.