Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2013 |
| Start Date: | November 2012 |
| End Date: | October 2014 |
| Contact: | Alison Nowak |
| Phone: | (617) 314-2694 |
A Single-center, Open-label Study Evaluating the Impact of Repeat Intravitreal Injections of Aflibercept on Capillary Non-Perfusion (CNP) in Subjects With Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal
Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or
Proliferative Diabetic Retinopathy (PDR).
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.
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