Clinical trial NCT01724554: Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Central Retinal Vein Occlusion
Proliferative Diabetic Retinopathy
Lead sponsor: Ophthalmic Consultants of Boston
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Protocol available upon request.

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.

Primary outcomes:
measure: Mean Change in Capillary Non-Perfusion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
affiliation: Ophthalmic Consultants of Boston
name: Jeffrey S Heier, MD
role: PRINCIPAL_INVESTIGATOR
References: