Clinical trial NCT01476449: Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Official title: Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Macular Edema
Keywords: Diabetic Macular Edema
Diabetic Retinal Swelling
DIabetic Eye Disease
Lead sponsor: Retina Vitreous Associates of Florida
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2011-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
timeFrame: Baseline through 24 months
Secondary outcomes:
measure: Mean Number of Injections.
timeFrame: 24 months
measure: Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
timeFrame: 24 months
measure: Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
timeFrame: 24 months
measure: Percentage of Patients Anatomically "Dry."
timeFrame: 24 Months
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
Study officials:
affiliation: Retina Vitreous Associates of Florida
name: David Eichenbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: