Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections
Overview
- Phase
- Phase 1
- Intervention
- Ranibizumab 0.5mg
- Conditions
- Neovascular Age-Related Macular Degeneration
- Sponsor
- Arshad Khanani
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evidence of Anterior Chamber Inflammation
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.
Detailed Description
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.
Investigators
Arshad Khanani
Vitreo-Retinal Surgeon
Sierra Eye Associates
Eligibility Criteria
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 -
Arms & Interventions
Ranibizumab 0.5mg Intravitreal injection
Intravitreal injection of Ranibizumab 0.5mg once
Intervention: Ranibizumab 0.5mg
Aflibercept 2.0mg Intravitreal injection
Intravitreal Aflibercept 2.0mg once
Intervention: Aflibercept 2.0mg
Outcomes
Primary Outcomes
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
- Patients With Post Injection Pain Score of One or Higher on Pain Scale(24 to 48 hours (visit #1) and 5 to 7 days (visit #2))