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Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

Primary Purpose

Uveitic Cystoid Macular Edema

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitic Cystoid Macular Edema focused on measuring Uveitis, Cystoid Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

  1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  2. Age > 18 years
  3. Non-infectious uveitis in study eye.
  4. Stable anti-uveitis medical regimen for at least one month prior to injection and controlled uveitis in the judgment of the investigator.
  5. Vision 20/40 or worse in study eye.
  6. Cystoid Macular Edema (CME) on fluorescein angiography (FA)
  7. Optical Coherence Tomography (OCT) demonstrating thickness greater than 300 microns in the central subfield.
  8. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography.

Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.

Exclusion Criteria:

  1. Previous intravitreal triamcinolone injection in study eye within 3 months of study injection.
  2. Use of more than two glaucoma medicines for study eye.
  3. Significant epiretinal membrane as judged by treating physician.
  4. Evidence of vitreomacular traction on OCT.
  5. Previous vitrectomy in study eye.
  6. Pregnancy (positive pregnancy test) or lactation.
  7. 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 intrauterine device (IUD), or contraceptive hormone implant or patch.
  8. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  9. Participation in another simultaneous IND trial.
  10. Treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks prior to enrollment in this study.
  11. Uncontrolled inflammation in the study eye.
  12. Current vitreous hemorrhage.
  13. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
  14. Known allergy to any component of the study drug.
  15. Intraocular pressure > 25 mm Hg despite treatment with glaucoma medications.
  16. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the subject can become eligible.
  17. Major non-ocular surgery planned during the next 6 months.
  18. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  19. No Avastin use permitted in fellow eye during study.
  20. Unwilling or unable to follow or comply with all study related procedures

Sites / Locations

  • Bascom Palmer Eye Insitute
  • Bascom Palmer of the Palm Beaches

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.
Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).

Secondary Outcome Measures

The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test.
The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months.
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test.
The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24.

Full Information

First Posted
January 20, 2009
Last Updated
August 24, 2014
Sponsor
University of Miami
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00826618
Brief Title
Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Official Title
Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis. Systemic and/or local corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and associated CME in many patients. However, in many cases, CME persists in spite of adequate suppression of uveitis. No consensus exists on how best to treat such cases. The further addition of immunosuppressive agents appears to have little effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged use can be associated with serious side-effects. Periocular and intravitreal corticosteroid injections are associated with well-known, significant side effects such as glaucoma and cataract formation. Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin interleukin (IL)-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it has been demonstrated that aqueous VEGF concentrations are statistically significantly higher in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our current knowledge of the pathophysiology of this condition and also because of the clinical need for additional treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in uveitis patients. The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and effective in leading to regression of macular edema due to chronic non-infectious uveitis in patients with well-controlled uveitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitic Cystoid Macular Edema
Keywords
Uveitis, Cystoid Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
Primary Outcome Measure Information:
Title
Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.
Description
Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test.
Time Frame
1 year
Title
The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months.
Time Frame
1 year
Title
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test.
Time Frame
1 year
Title
The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age > 18 years Non-infectious uveitis in study eye. Stable anti-uveitis medical regimen for at least one month prior to injection and controlled uveitis in the judgment of the investigator. Vision 20/40 or worse in study eye. Cystoid Macular Edema (CME) on fluorescein angiography (FA) Optical Coherence Tomography (OCT) demonstrating thickness greater than 300 microns in the central subfield. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography. Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study. Exclusion Criteria: Previous intravitreal triamcinolone injection in study eye within 3 months of study injection. Use of more than two glaucoma medicines for study eye. Significant epiretinal membrane as judged by treating physician. Evidence of vitreomacular traction on OCT. Previous vitrectomy in study eye. 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 intrauterine device (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 IND trial. Treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks prior to enrollment in this study. Uncontrolled inflammation in the study eye. Current vitreous hemorrhage. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. Known allergy to any component of the study drug. Intraocular pressure > 25 mm Hg despite treatment with glaucoma medications. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the subject can become eligible. Major non-ocular surgery planned during the next 6 months. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. No Avastin use permitted in fellow eye during study. Unwilling or unable to follow or comply with all study related procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Albini, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Insitute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Bascom Palmer of the Palm Beaches
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States

12. IPD Sharing Statement

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Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

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