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

Primary Purpose

Central Retinal Vein Occlusion, Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravitreal Aflibercept Injection
Sponsored by
Ophthalmic Consultants of Boston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ophthalmic Consultants of Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Every Month Treatment

Every Month, then Every Other Month

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2012
Last Updated
May 21, 2015
Sponsor
Ophthalmic Consultants of Boston
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01724554
Brief Title
Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthalmic Consultants of Boston
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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).
Detailed Description
Protocol available upon request.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion, Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Every Month Treatment
Arm Type
Experimental
Arm Description
Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.
Arm Title
Every Month, then Every Other Month
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection
Other Intervention Name(s)
IAI
Intervention Description
Aflibercept administered to the eye intravitreally either every month or every other month.
Primary Outcome Measure Information:
Title
Mean Change in Capillary Non-Perfusion
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Heier, MD
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

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