Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476449
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : October 5, 2016
Genentech, Inc.
Information provided by (Responsible Party):
Retina Vitreous Associates of Florida

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Drug: Ranibizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
Study Start Date : November 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: 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.
Drug: Ranibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Other Name: Lucentis

Experimental: 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.
Drug: Ranibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Other Name: Lucentis

Primary Outcome Measures :
  1. Mean change in Early Treatment for Diabetic Retinopathy Study (ETDRS) eye chart vision. [ Time Frame: 12 months ]
    The ETDRS eye chart will be used to check the vision at each visit throuh month 12. The improvement or worsening in vision as measured on the eye chart over that time will be recorded.

Secondary Outcome Measures :
  1. Mean number of injections. [ Time Frame: 12 months ]
    The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.

  2. Mean change in spectral domain optical coherence tomography (SD-OCT) central foveal thickness (CFT). [ Time Frame: 12 months ]
    Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.

  3. Percentage of patients with best corrected visual acuity (BCVA) Snellen-equivalent of 20/40 or better. [ Time Frame: 12 months ]
    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.

  4. Percentage of patients anatomically "dry." [ Time Frame: 3, 6, and 12 months. ]
    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.

  5. Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 12 months ]
    To evaluate the safety and tolerability of ranibizumab for diabetic macular edema by recording local and systemic adverse events.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01476449

United States, Florida
Retina Vitreous Associates of Florida
Clearwater, Florida, United States, 33756
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711
Sponsors and Collaborators
Retina Vitreous Associates of Florida
Genentech, Inc.
Principal Investigator: David Eichenbaum, MD Retina Vitreous Associates of Florida

Additional Information:
Responsible Party: Retina Vitreous Associates of Florida Identifier: NCT01476449     History of Changes
Other Study ID Numbers: 1127228
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: November 2014

Keywords provided by Retina Vitreous Associates of Florida:
Diabetic Macular Edema
Diabetic Retinal Swelling
DIabetic Eye Disease

Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents