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

Sponsors and Collaborators:	Rush University Medical Center Genentech
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00606138

Purpose

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.

Condition	Intervention	Phase
Proliferative Diabetic Retinopathy	Drug: ranibizumab Procedure: Laser photocoagulation	Phase I Phase II

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Investigation of Ranibizumab for the Treatment of Persistent Diabetic Neovascularization as Assessed by Super Wide-Field Angiography (Optos)

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	10
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intravitreal injection of 0.5-mg dose of ranibizumab	Drug: ranibizumab One 0.5 mg intravitreal injection
2: Active Comparator Additional panretinal photocoagulation (up to 500 300-500 um laser spots)	Procedure: Laser photocoagulation panretinal photocoagulation (up to 500 300-500 um laser spots)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606138

Contacts

Contact: Mathew W MacCumber, MD, PhD

312-942-2117

macretina@aol.com

Locations

United States, Illinois
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Mathew W MacCumber, MD, PhD 312-942-2117 macretina@aol.com
Principal Investigator: Mathew W MacCumber, MD, PhD
Sub-Investigator: Jack A Cohen, MD
Sub-Investigator: Michael J Davis, MD
Sub-Investigator: Pauline T Merrill, MD
Sub-Investigator: Kirk H Packo, MD

Sponsors and Collaborators

Rush University Medical Center

Genentech

Investigators

Principal Investigator:

Mathew W MacCumber, MD, PhD

Rush University Medical Center

More Information

Responsible Party:	Rush University Medical Center ( Mathew W. MacCumber, MD, PhD )
Study ID Numbers:	06120402
Study First Received:	January 9, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00606138
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Diabetic Retinopathy
Metaplasia
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Endocrinopathy
Neovascularization, Pathologic
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009