Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

Proliferative Diabetic Retinopathy Clinical Trial

— ANDROID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724554
• Other study ID #: ANDROID
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 7, 2012
• Last updated: May 21, 2015
• Start date: November 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Ophthalmic Consultants of Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

Protocol available upon request.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Retinal Vein Occlusion

Intervention

Drug:
• Intravitreal Aflibercept Injection
Aflibercept administered to the eye intravitreally either every month or every other month.

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Boston	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No