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

Phase 2

Completed

Conditions: Diabetic Macular Edema

Interventions: Drug: Ranibizumab 0.3 mg
Drug: Aflibercept 2.0 mg

Registration Number: NCT02363621

Lead Sponsor: Arshad Khanani

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.3 Intravitreal injection	Ranibizumab 0.3 mg	Intravitreal injection of Ranibizumab 0.3 mg once
Aflibercept 2.0 mg intravitreal injection	Aflibercept 2.0 mg	Intravitreal Aflibercept 2.0 mg once

Primary Outcome Measures

Name	Time	Method
Number of Participants With Intraocular Inflammation	5 to 7 days (visit #2)	Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.	24 to 48 hours visit #1 and 5 to 7 days visit #2	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