Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME

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 0.3mg and aflibercept 2.0mg in patients with DME. The investigators will be evaluating patients (1-7 days) post injections for: 1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).

Detailed Description
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This is an open-label, Phase II study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with Diabetic Macular Edema. Treatment naïve and experienced patients will be enrolled. Treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. Patients will be randomized to receive either Lucentis 0.3 mg or Eylea 2.0 mg, and followed for a week. A non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. Pain will also be recorded at these visits using a standardized pain scale. Consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber and vitreous 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 Nomenculature (SUN) working group classifications. Pain score will be evaluated using a Numerical Rating Scale.

Official Title
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Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs. Aflibercept in Patients With Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab 0.3 mg
* Drug: Aflibercept 2.0 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 21 years Exam and OCT confirming Diabetic Macular Edema Visual Acuity of 20/400 or better No history of post injection pain or inflammation in the past Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study History of Endophthalmitis in either eye Current inflammation in either eye Uncontrolled or symptomatic Dry Eye Syndrome Intravitreal injection less than 3 months ago History of Anterior or Posterior Uveitis History of post injection pain 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: 21 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab 0.3 Intravitreal injection<br>Intravitreal injection of Ranibizumab 0.3 mg once | Drug: Ranibizumab 0.3 mg<br>* Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg<br>* Other names: Lucentis;|
| Active Comparator: Aflibercept 2.0 mg intravitreal injection<br>Intravitreal Aflibercept 2.0 mg once | Drug: Aflibercept 2.0 mg<br>* Patient will receive intravitreal injection of Aflibercept 2.0 mg<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Intraocular Inflammation | Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam. | 24 to 48 hours (visit #1) | 
| Number of Participants With Intraocular Inflammation | Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam | 5 to 7 days (visit #2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale. | Pain score rated on a 11 point numerical rating from 0-10 administered to each patient verbally at visit #1 and visit #2. 0 = no pain 10 = severe pain | 24 to 48 hours visit #1 and 5 to 7 days visit #2 |