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NCT Number: NCT01942213

Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients.

This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.

Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.

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Key information

Conditions

Neovascular Age Related Macular Degeneration

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NJ Retina

Edison, New Jersey, 08820, United States

About this study

Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.

Inclusion criteria

  • Ability to provide written informed consent and comply with study
  • Age 65-90 years
  • Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept

Exclusion criteria

  • Previous intraocular inflammation
  • Treatment with systemic anti-inflammatory agents
  • Known systemic autoimmune diseases
  • Treatment with intraocular steroids in the past 3 months
  • History of intraocular surgery in the past 3 months
  • Age greater than 90 years
  • Patients who were switched between either therapies in the past 3 months

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age 65-90 years
  • Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept

Exclusion criteria

  • Previous intraocular inflammation
  • Treatment with systemic anti-inflammatory agents
  • Known systemic autoimmune diseases
  • Treatment with intraocular steroids in the past 3 months
  • History of intraocular surgery in the past 3 months
  • Age greater than 90 years
  • Patients who were switched between either therapies in the past 3 months

Treatment and study plan

Primary outcomes

  1. To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.

    Time frame: 2-3 days after injection

    All eyes will be evaluated 2-3 days after injection and graded in terms of (a) aqueous cells, graded subjectively on a scale of 0-4, (b) aqueous flare, graded subjectively on a scale 0-4, (c) aqueous flare graded objectively with the FM-600 Kowa flare meter and (d) vitreous haze, graded subjectively on a scale of 0-4.

Secondary outcomes

  1. To evaluate patients 2-3 days post-injection for best corrected visual acuity

    Time frame: 2-3 days post-injection

    Best corrected visual acuity will be assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study eye chart at a starting test distance of 4 meters.

Other outcomes

  1. To evaluate patient's pain post-injection

    Time frame: 2-3 days post-injection

    Pain will be measured on a standardized pain scale; Visual Function Questionaire -25 and a 0-10 numeric pain scale.

Sponsors and collaborators

Lead sponsor

Prism Vision Group

Other

Registry information

Official study title

Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2013
Registry last updated
Jun 1, 2016

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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