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Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Primary Purpose

Diabetic Retinopathy, Macular Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab
Sponsored by
Retina Vitreous Associates of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Macular Edema, Diabetic Retinal Swelling, DIabetic Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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
  • Patient related considerations
  • Phakic or pseudophakic patients with a known history of diabetes will be eligible.
  • Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
  • Disease related considerations:
  • Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
  • Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
  • Central foveal thickness on SD-OCT of >300um

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • 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
  • Foveal ischemia on IVFA
  • Intraocular surgery less than 6 months ago
  • Epiretinal membrane of clinical significance
  • Prior vitrectomy
  • Uncontrolled glaucoma
  • Macular or peripheral laser within 90 Days from Day 0 injection
  • Intravitreal steroid injection within 90 days from Day 0 injection
  • Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection

Sites / Locations

  • Retina Vitreous Associates of Florida
  • Retina Vitreous Associates of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monthly Ranibizumab

Treat and Extend Ranibizumab

Arm Description

Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.

Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.

Outcomes

Primary Outcome Measures

Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.

Secondary Outcome Measures

Mean Number of Injections.
The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
Percentage of Patients Anatomically "Dry."
Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.

Full Information

First Posted
November 13, 2011
Last Updated
April 23, 2019
Sponsor
Retina Vitreous Associates of Florida
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01476449
Brief Title
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Official Title
Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Retina Vitreous Associates of Florida
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
Detailed Description
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Edema
Keywords
Diabetic Macular Edema, Diabetic Retinal Swelling, DIabetic Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monthly Ranibizumab
Arm Type
Active Comparator
Arm Description
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Arm Title
Treat and Extend Ranibizumab
Arm Type
Experimental
Arm Description
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Primary Outcome Measure Information:
Title
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
Description
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Time Frame
Baseline through 24 months
Secondary Outcome Measure Information:
Title
Mean Number of Injections.
Description
The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
Time Frame
24 months
Title
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Description
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
Time Frame
24 months
Title
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
Description
The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
Time Frame
24 months
Title
Percentage of Patients Anatomically "Dry."
Description
Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
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 Patient related considerations Phakic or pseudophakic patients with a known history of diabetes will be eligible. Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug. Disease related considerations: Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication. Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40 Central foveal thickness on SD-OCT of >300um Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. 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 Foveal ischemia on IVFA Intraocular surgery less than 6 months ago Epiretinal membrane of clinical significance Prior vitrectomy Uncontrolled glaucoma Macular or peripheral laser within 90 Days from Day 0 injection Intravitreal steroid injection within 90 days from Day 0 injection Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Eichenbaum, MD
Organizational Affiliation
Retina Vitreous Associates of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Vitreous Associates of Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.retinavitreous.com
Description
Study Sponsor: Retina Vitreous Associates of Florida

Learn more about this trial

Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

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