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Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

This study is currently recruiting participants.
Verified November 2011 by Retina Vitreous Associates of Florida
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Retina Vitreous Associates of Florida
ClinicalTrials.gov Identifier:
NCT01476449
First received: November 13, 2011
Last updated: July 19, 2012
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Macular Edema
 Drug: Ranibizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Retina Vitreous Associates of Florida:

Primary Outcome Measures:
  • Mean change in Early Treatment for Diabetic Retinopathy Study (ETDRS) eye chart vision. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Mean number of injections. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.

  • Mean change in spectral domain optical coherence tomography (SD-OCT) central foveal thickness (CFT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.

  • Percentage of patients with best corrected visual acuity (BCVA) Snellen-equivalent of 20/40 or better. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of patients anatomically "dry." [ Time Frame: 3, 6, and 12 months. ] [ Designated as safety issue: No ]
    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.

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


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476449

Contacts
Contact: David Eichenbaum, MD 727-323-0077

Locations
United States, Florida
Retina Vitreous Associates of Florida Recruiting
Clearwater, Florida, United States, 33756
Contact: David Eichenbaum, MD     727-445-9110        
Principal Investigator: David Eichenbaum, MD            
Retina Vitreous Associates of Florida Recruiting
St. Petersburg, Florida, United States, 33711
Contact: David Eichenbaum, MD     727-323-0077        
Principal Investigator: David Eichenbaum, MD            
Sponsors and Collaborators
Retina Vitreous Associates of Florida
Genentech
Investigators
Principal Investigator: David Eichenbaum, MD Retina Vitreous Associates of Florida
  More Information

Additional Information:
Study Sponsor: Retina Vitreous Associates of Florida  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Retina Vitreous Associates of Florida
ClinicalTrials.gov Identifier: NCT01476449     History of Changes
Other Study ID Numbers: 1127228
Study First Received: November 13, 2011
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on June 18, 2013