Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion (ANDROID)

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).

Study Overview

• Status: Completed
• Conditions: Central Retinal Vein Occlusion; Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: Intravitreal Aflibercept Injection

Detailed Description

Protocol available upon request.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Every Month Treatment; Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.	Drug: Intravitreal Aflibercept Injection; Aflibercept administered to the eye intravitreally either every month or every other month.; Other Names: IAI
Experimental: Every Month, then Every Other Month; 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.	Drug: Intravitreal Aflibercept Injection; Aflibercept administered to the eye intravitreally either every month or every other month.; Other Names: IAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Capillary Non-Perfusion	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.	12 months

Collaborators and Investigators

• Sponsor: Ophthalmic Consultants of Boston
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Diseases; Diabetic Retinopathy; Retinal Vein Occlusion; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: ANDROID