Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Diabetic Retinopathy Clinical Trial

Official title:

Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476449
• Other study ID #: 1127228
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: September 2016

Study information

• Verified date: April 2019
• Source: Retina Vitreous Associates of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Drug:
• Ranibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
• Ranibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Locations

Country	Name	City	State
United States	Retina Vitreous Associates of Florida	Clearwater	Florida
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Retina Vitreous Associates of Florida	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.	The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.	Baseline through 24 months
Secondary	Mean Number of Injections.	The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.	24 months
Secondary	Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).	Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.	24 months
Secondary	Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.	The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.	24 months
Secondary	Percentage of Patients Anatomically "Dry."	Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.	24 Months

External Links

•   Study Sponsor: Retina Vitreous Associates of Florida