Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

NCT ID: NCT01476449

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-09-30

Brief Summary

This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

Detailed Description

This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.

Conditions

Diabetic Retinopathy; Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monthly Ranibizumab

Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Treat and Extend Ranibizumab

Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Interventions

Ranibizumab

Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Intervention Type: DRUG

Ranibizumab

Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Intervention Type: DRUG

Other Intervention Names

Lucentis; Lucentis

Eligibility Criteria

Inclusion Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 18 years
• Patient related considerations
• Phakic or pseudophakic patients with a known history of diabetes will be eligible.
• Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
• Disease related considerations:
• Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
• Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
• Central foveal thickness on SD-OCT of >300um

Exclusion Criteria

• Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• Foveal ischemia on IVFA
• Intraocular surgery less than 6 months ago
• Epiretinal membrane of clinical significance
• Prior vitrectomy
• Uncontrolled glaucoma
• Macular or peripheral laser within 90 Days from Day 0 injection
• Intravitreal steroid injection within 90 days from Day 0 injection
• Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Retina Vitreous Associates of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Eichenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Vitreous Associates of Florida

Locations

Retina Vitreous Associates of Florida

Clearwater, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

1127228

Identifier Type: -

Identifier Source: org_study_id