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

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ranibizumab

Laser photocoagulation

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anti-VEGF injection

PRP Laser

Arm Description

Intravitreal injection of 0.5-mg dose of ranibizumab

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

Outcomes

Primary Outcome Measures

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.

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

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

Number of Participants With Occurrence of Adverse Events

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

Secondary Outcome Measures

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

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

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

Complications; including vitreous hemorrhage, iris neovascularization, and tractional retinal detachment were assessed at the 6 month time point and are reported below.

Full Information

NCT ID

NCT00606138

First Posted

January 9, 2008

Last Updated

April 5, 2023

Sponsor

Rush University Medical Center

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00606138

Brief Title

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

Official Title

Investigation of Ranibizumab for the Treatment of Persistent Diabetic Neovascularization as Assessed by Super Wide-Field Angiography (Optos)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rush University Medical Center

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anti-VEGF injection

Arm Type

Experimental

Arm Description

Intravitreal injection of 0.5-mg dose of ranibizumab

Arm Title

PRP Laser

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

One 0.5 mg intravitreal injection

Intervention Type

Procedure

Intervention Name(s)

Laser photocoagulation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 4; Baseline to Month 4-6

Title

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

Title

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

Time Frame

Month 6

Title

Number of Participants With Occurrence of Adverse Events

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

1 month, 6 months

Title

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

Description

Complications; including vitreous hemorrhage, iris neovascularization, and tractional retinal detachment were assessed at the 6 month time point and are reported below.

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathew W MacCumber, MD, PhD

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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