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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Ranibizumab 0.3 mg; Drug: Aflibercept 2.0 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ranibizumab 0.3 Intravitreal injection; Intravitreal injection of Ranibizumab 0.3 mg once	Drug: Ranibizumab 0.3 mg; Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg; Other Names: Lucentis
Active Comparator: Aflibercept 2.0 mg intravitreal injection; Intravitreal Aflibercept 2.0 mg once	Drug: Aflibercept 2.0 mg; Patient will receive intravitreal injection of Aflibercept 2.0 mg; Other Names: Eylea

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arshad Khanani
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Inflammation; Macular Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: ML29634