Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Retina Vitreous Associates of Florida

Status and phase: Completed; Phase 2

Conditions: Macular Edema; Diabetic Retinopathy

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01476449

1127228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Monthly Ranibizumab

Active Comparator group

Description:

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.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Treat and Extend Ranibizumab

Experimental group

Description:

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.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab