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

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

Detailed Description
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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.

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

Conditions
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Neovascular Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab 0.5mg
* Drug: Aflibercept 2.0mg


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab 0.5mg Intravitreal injection<br>Intravitreal injection of Ranibizumab 0.5mg once | Drug: Ranibizumab 0.5mg<br>* Patient will receive intravitreal injection of Ranibizumab 0.5mg.<br>* Other names: Lucentis;|
| Active Comparator: Aflibercept 2.0mg Intravitreal injection<br>Intravitreal Aflibercept 2.0mg once | Drug: Aflibercept 2.0mg<br>* Patients will receive intravitreal injection of Aflibercept 2.0mg.<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Anterior Chamber Inflammation | Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN) | 24 to 48 hours (visit #1) and 5 to 7 days (visit #2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Post Injection Pain Score of One or Higher on Pain Scale | 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. | 24 to 48 hours (visit #1) and 5 to 7 days (visit #2) |