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

NCT00606138 | Completed Phase 1 Results

• 1 other identifier: 06120402
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (4)

• The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)

  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

• The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)

  Baseline to Week 4; Baseline to Month 6

• Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination

  Month 6

• Number of Participants With Occurrence of Adverse Events

  Patients were randomized to receive IVR vs. additional PRP. Number of participants with adverse events.

  Week 1, 2, 4; Month 2, 3, 4, 5, 6

Secondary Outcomes (3)

• 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

  1 Month; 6 months

• Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing

  1 month, 6 months

• Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment

  6 month

Study Arms (2)

Anti-VEGF injection

EXPERIMENTAL

Intravitreal injection of 0.5-mg dose of ranibizumab

Drug: ranibizumab

PRP Laser

ACTIVE COMPARATOR

Additional panretinal photocoagulation (up to 500 300-500 um laser spots)

Procedure: Laser photocoagulation

Interventions

ranibizumab DRUG

One 0.5 mg intravitreal injection

Also known as: Lucentis

Anti-VEGF injection

Laser photocoagulation PROCEDURE

panretinal photocoagulation (up to 500 300-500 um laser spots)

PRP Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Mathew MacCumber, MD, PhD
• Organization: Rush University Medical Center

denise_voskuil-marre@rush.edu

312-563-4032

Study Officials

• Mathew W MacCumber, MD, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: February 1, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 10, 2023
• Results First Posted: November 6, 2014

Record last verified: 2023-04

Locations

US (1)