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

NCT ID: NCT02363621

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-10-31

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ranibizumab 0.3 Intravitreal injection

Intravitreal injection of Ranibizumab 0.3 mg once

Group Type: ACTIVE_COMPARATOR

Ranibizumab 0.3 mg

Intervention Type: DRUG

Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg

Aflibercept 2.0 mg intravitreal injection

Intravitreal Aflibercept 2.0 mg once

Group Type: ACTIVE_COMPARATOR

Aflibercept 2.0 mg

Intervention Type: DRUG

Patient will receive intravitreal injection of Aflibercept 2.0 mg

Interventions

Ranibizumab 0.3 mg

Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg

Intervention Type: DRUG

Aflibercept 2.0 mg

Patient will receive intravitreal injection of Aflibercept 2.0 mg

Intervention Type: DRUG

Other Intervention Names

Lucentis; Eylea

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Arshad Khanani

OTHER

Sponsor Role: lead

Responsible Party

Arshad Khanani

Vitreo-Retinal Diseases and Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arshad Khanani, MD

Role: PRINCIPAL_INVESTIGATOR

Sierra Eye Associates

Locations

Sierra Eye Associates

Reno, Nevada, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ML29634

Identifier Type: -

Identifier Source: org_study_id