Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

NCT01724554 | Completed Phase 1

• 1 other identifier: ANDROID
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Central Retinal Vein Occlusion; Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Every Month Treatment

EXPERIMENTAL

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

Drug: Intravitreal Aflibercept Injection

Every Month, then Every Other Month

EXPERIMENTAL

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

Interventions

Intravitreal Aflibercept Injection DRUG

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

Also known as: IAI

Every Month Treatment; Every Month, then Every Other Month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Be in need of IAI treatment, whether previously treated or treatment-naïve.
• Age \> 18 years.

You may not qualify if:

• Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
• Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
• 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.
• Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
• Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
• Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
• History of vitrectomy surgery in the study eye.
• Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
• Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
• Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
• Pregnant or breast-feeding women.

Sponsors & Collaborators

• Ophthalmic Consultants of Boston: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jeffrey S Heier, MD

  Ophthalmic Consultants of Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 9, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (1)