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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363621
• Other study ID #: ML29634
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: April 2019
• Source: Sierra Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Inflammation
• Macular Edema

Intervention

Drug:
• Ranibizumab 0.3 mg
Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg
• Aflibercept 2.0 mg
Patient will receive intravitreal injection of Aflibercept 2.0 mg

Locations

Country	Name	City	State
United States	Sierra Eye Associates	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Arshad Khanani	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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