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Completed

NCT Number: NCT01926977

Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sierra Eye Associates

Reno, Nevada, 89502, United States

About this study

This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).

The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.

Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenclature (SUN) working group classifications.

Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to provide informed consent and comply with study assessments for the full duration of the study
  • Age >/= 65 years
  • New onset Neovascular Age-Related Macular Degeneration or (See No.4)
  • Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
  • Visual Acuity of 20/400 or better
  • No history of Post injection pain or inflammation with prior treatments -

Exclusion criteria

  • History of Endophthalmitis in either eye
  • Uncontrolled or symptomatic Dry Eye Syndrome
  • History of Anterior or Posterior Uveitis
  • History of Post injection pain or inflammation with prior treatments
  • Recent thromboembolic event(<3 months)
  • Pregnancy(positive pregnancy test) or Lactation/Premenopausal women not using adequate contraception -

Treatment and study plan

Ranibizumab 0.5mg

Drug

Patient will receive intravitreal injection of Ranibizumab 0.5mg.

Other names: Lucentis

Aflibercept 2.0mg

Drug

Patients will receive intravitreal injection of Aflibercept 2.0mg.

Other names: Eylea

Primary outcomes

  1. Evidence of Anterior Chamber Inflammation

    Time frame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)

    Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)

Secondary outcomes

  1. Patients With Post Injection Pain Score of One or Higher on Pain Scale

    Time frame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)

    Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.

Sponsors and collaborators

Lead sponsor

Arshad Khanani

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2013
Registry last updated
Mar 3, 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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