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Trial record 54 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724554
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : May 22, 2015
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Ophthalmic Consultants of Boston

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).

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

Detailed Description:
Protocol available upon request.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

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 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

Primary Outcome Measures :
  1. Mean Change in Capillary Non-Perfusion [ Time Frame: 12 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01724554

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

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Responsible Party: Ophthalmic Consultants of Boston Identifier: NCT01724554     History of Changes
Other Study ID Numbers: ANDROID
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

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