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OpenTrials
Completed

NCT Number: NCT01724554

Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

About this study

Protocol available upon request.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal aflibercept injection

Drug

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

Other names: IAI

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ophthalmic Consultants of Boston

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: ANDROID

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2012
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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