Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

Phase 1

Completed

• Conditions: Central Retinal Vein Occlusion; Proliferative Diabetic Retinopathy
• Interventions: Drug: Intravitreal Aflibercept Injection

• Registration Number: NCT01724554
• Lead Sponsor: Ophthalmic Consultants of Boston

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Every Month, then Every Other Month	Intravitreal Aflibercept Injection	Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.
Every Month Treatment	Intravitreal Aflibercept Injection	Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.

Primary Outcome Measures

Name	Time	Method
Mean Change in Capillary Non-Perfusion	12 months	To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.

Trial Locations

Locations (1)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States