- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606138
Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging
April 5, 2023 updated by: Rush University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anti-VEGF injection
Intravitreal injection of 0.5-mg dose of ranibizumab
|
One 0.5 mg intravitreal injection
Other Names:
|
Active Comparator: PRP Laser
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
panretinal photocoagulation (up to 500 300-500 um laser spots)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination
Time Frame: Month 6
|
Month 6
|
|
The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)
Time Frame: Baseline to Week 4; Baseline to Month 4-6
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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.
|
Baseline to Week 4; Baseline to Month 4-6
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The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)
Time Frame: Baseline to Week 4; Baseline to Month 6
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Baseline to Week 4; Baseline to Month 6
|
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Number of Participants With Occurrence of Adverse Events
Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6
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Patients were randomized to receive IVR vs. additional PRP.
Number of participants with adverse events.
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Week 1, 2, 4; Month 2, 3, 4, 5, 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Lines Gained on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters
Time Frame: 1 Month; 6 months
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1 Month; 6 months
|
|
Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing
Time Frame: 1 month, 6 months
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1 month, 6 months
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Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment
Time Frame: 6 month
|
Complications; including vitreous hemorrhage, iris neovascularization, and tractional retinal detachment were assessed at the 6 month time point and are reported below.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mathew W MacCumber, MD, PhD, Rush University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
January 9, 2008
First Submitted That Met QC Criteria
January 31, 2008
First Posted (Estimate)
February 1, 2008
Study Record Updates
Last Update Posted (Actual)
April 10, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Metaplasia
- Diabetic Retinopathy
- Neovascularization, Pathologic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- 06120402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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