Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

NCT ID: NCT01724554

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-10-31

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.

Conditions

Central Retinal Vein Occlusion; Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Every Month Treatment

Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.

Group Type: EXPERIMENTAL

Intravitreal Aflibercept Injection

Intervention Type: DRUG

Aflibercept administered to the eye intravitreally either every month or every other month.

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.

Group Type: EXPERIMENTAL

Intravitreal Aflibercept Injection

Intervention Type: DRUG

Aflibercept administered to the eye intravitreally either every month or every other month.

Interventions

Intravitreal Aflibercept Injection

Aflibercept administered to the eye intravitreally either every month or every other month.

Intervention Type: DRUG

Other Intervention Names

IAI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Ophthalmic Consultants of Boston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey S Heier, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Locations

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

ANDROID

Identifier Type: -

Identifier Source: org_study_id