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Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00606138
First received: January 9, 2008
Last updated: November 4, 2014
Last verified: November 2014

January 9, 2008
November 4, 2014
January 2008
October 2010   (final data collection date for primary outcome measure)
  • The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography) [ Time Frame: Week 4; Month 6 ] [ Designated as safety issue: No ]
    This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.
  • The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography) [ Time Frame: Week 4; Month 6 ] [ Designated as safety issue: No ]
  • Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: Yes ]
  • The percentage change of the area of the patient's neovascularization as measured in pixels by Optomap FA [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • The percentage change of macular edema measured by retinal thickness by OCT [ Time Frame: Week 2, 4; Month 2, 3, 4, 6 ] [ Designated as safety issue: No ]
  • Incidence and severity of ocular adverse events, as identified by ophthalmic examination [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: Yes ]
  • Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00606138 on ClinicalTrials.gov Archive Site
  • Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters [ Time Frame: Week 4; Month 6 ] [ Designated as safety issue: No ]
  • Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Mean change in Best Corrected Visual Acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Percentage of patients gaining 3 or more lines of vision according to ETDRS eye chart testing [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Occurrence rate of proliferative diabetic complications including vitreous hemorrhage, iris neovascularization, and tractional retinal detachment [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging
Investigation of Ranibizumab for the Treatment of Persistent Diabetic Neovascularization as Assessed by Super Wide-Field Angiography (Optos)

Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual treatment is a type of laser, called panretinal photocoagulation. One drawback is that the amount of space within the eye for use of this treatment eventually has its limit, and should not be used too near the part of the retina used for detailed vision (the macula). In similar eye disorders, there are certain injectable medications called anti-VEGF treatments which can slow down or stop this abnormal blood vessel growth. This study sought to compare use of ranibizumab versus standard panretinal photocoagulation in treatment of diabetic neovascularization.

The purpose is to compare the efficacy of ranibizumab versus additional panretinal photocoagulation on diabetic neovascularization that is persistent despite previous treatment with panretinal photocoagulation. We hypothesize that ranibizumab intravitreal injections would induce neovascular regression in similar or better fashion than supplemental laser photocoagulation. Consented, enrolled subjects will either receive open-label intravitreal injections of 0.5-mg dose of ranibizumab or additional panretinal photocoagulation (up to 500 300-500 um laser spots) in a ratio of two-to-one (2:1) at the beginning of the study period. ETDRS best-corrected visual acuity, contrast sensitivity, and Optos color photography will be performed at enrollment, at weeks 1, 2, 3 and 4, and at months 2, 3, 4, 5 and 6. The subjects will undergo fluorescein angiography utilizing the Optomap FA (fluorescein angiography) system and optical coherence tomography (OCT) at enrollment, at weeks 2 and 4, and at months 2, 3, 4 and 6. The subjects will be followed for a 6-month period for stabilization, regression, or recurrence of neovascularization. In addition, patients will be evaluated for occurrence of macular edema.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
  • Drug: ranibizumab
    One 0.5 mg intravitreal injection
    Other Name: Lucentis
  • Procedure: Laser photocoagulation
    panretinal photocoagulation (up to 500 300-500 um laser spots)
  • Experimental: Anti-VEGF injection
    Intravitreal injection of 0.5-mg dose of ranibizumab
    Intervention: Drug: ranibizumab
  • Active Comparator: PRP Laser
    Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
    Intervention: Procedure: Laser photocoagulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age 18 years or older

Patient related considerations:

  • Patients with Diabetes Mellitus (Type I or II) are eligible. HgA1c will be evaluated at the beginning of the study, but this value will have no significance in inclusion or exclusion.
  • Patients will not be pregnant at enrollment and must provide evidence of the use of two types of birth control while enrolled in the study.
  • Patients will have no known sensitivity to ranibizumab or other anti-VEGF injections.

Disease related considerations:

  • Patients will have diabetic neovascularization as seen on fluorescein angiography that was previously treated with full (at least 1200 laser burns) panretinal photocoagulation and that has persisted at least three months.
  • There will be no evidence of ocular inflammation at enrollment.
  • There is no restriction on patient's current medications or concomitant illnesses as long as there is no interference with patient follow-up.

Other considerations:

  • Patients may not be enrolled in another clinical study or observational trial.
  • There is no limitation on patient's institutional status as long as the patient is able to participate in follow-up.

Exclusion Criteria:

  • Pregnancy (positive pregnancy test)
  • Uncontrolled glaucoma on three medicines or more to control intraocular pressure
  • Prior enrollment in the study
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606138
06120402
No
Rush University Medical Center
Rush University Medical Center
Genentech, Inc.
Principal Investigator: Mathew W MacCumber, MD, PhD Rush University Medical Center
Rush University Medical Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP