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

This study is currently recruiting participants.
Verified November 2012 by Ophthalmic Consultants of Boston
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:
NCT01724554
First received: November 7, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Central Retinal Vein Occlusion
Proliferative Diabetic Retinopathy
 Drug: Intravitreal Aflibercept Injection
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Aflibercept
U.S. FDA Resources

Further study details as provided by Ophthalmic Consultants of Boston:

Primary Outcome Measures:
  • Mean Change in Capillary Non-Perfusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: IAI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724554

Contacts
Contact: Alison Nowak (617) 314-2694

Locations
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Jeffrey S. Heier, MD            
Sponsors and Collaborators
Ophthalmic Consultants of Boston
Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier: NCT01724554     History of Changes
Other Study ID Numbers: ANDROID
Study First Received: November 7, 2012
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Retinal Vein Occlusion
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis

ClinicalTrials.gov processed this record on May 22, 2013