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ANDROID: Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

Sponsor
Ophthalmic Consultants of Boston (Other)
Overall Status
Completed
CT.gov ID
NCT01724554
Collaborator
Regeneron Pharmaceuticals (Industry)
24
Enrollment
1
Location
2
Arms
23
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Intravitreal Aflibercept Injection
 Phase 1/Phase 2

Detailed Description

Protocol available upon request.

Study Design

Study Type:
Interventional
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 :
Nov 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

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 Names:
  • 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 Names:
  • IAI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change in Capillary Non-Perfusion [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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).

    1. Be in need of IAI treatment, whether previously treated or treatment-naïve.

    2. 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

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Ophthalmic Consultants of Boston
    • Regeneron Pharmaceuticals

    Investigators

    • Principal Investigator: Jeffrey S Heier, MD, Ophthalmic Consultants of Boston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ophthalmic Consultants of Boston
    ClinicalTrials.gov Identifier:
    NCT01724554
    Other Study ID Numbers:
    • ANDROID
    First Posted:
    Nov 9, 2012
    Last Update Posted:
    May 22, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Retinal Vein Occlusion
    Aflibercept

    Study Results

    No Results Posted as of May 22, 2015