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Lucentis for Inflammatory Macular Edema Trial (LIME)

Primary Purpose

Uveitis, Cytoid Macular Edema

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Uveitis focused on measuring uveitis, cytoid macular edema, steroid, Lucentis

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
A history of non-infectious uveitis with chronic cystoid macular edema (> 3 months duration)
Foveal retinal thickness of ≥ 300 µM by OCT testing
One prior trial of oral or regional steroid treatment for CME ≥ 30 days prior to study enrollment with persistent CME (≥ 300 µM foveal retinal thickness on OCT) or inability to use steroid injections due to a history of increased IOP above 30 mmHg thought to be due to topical steroid treatment or prior steroid injections
Anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation
BCVA at 4 m using the ETDRS chart of 20/40 to 20/400 (Snellen equivalent) in the study eye
Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

Pregnancy (positive pregnancy test) or known to be pregnant, or premenopausal but not using adequate contraception
Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study. Study subjects will be allowed to continue their immunomodulatory treatment for uveitis throughout the study.
Previous vitrectomy
Active intraocular inflammation in the study eye (greater than trace anterior chamber or vitreous cells)
Current vitreous hemorrhage
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Known allergy to any component of the study drug
Intraocular pressure > 30 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 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
Participation in another simultaneous medical investigation or trial
Unwilling or unable to follow or comply with all study related procedures

Sites / Locations

Proctor Foundation, UCSF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.

Outcomes

Primary Outcome Measures

The Mean Change at 3 Months in BSCVA From Baseline

The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.

Secondary Outcome Measures

The Median Change in Best Corrected Visual Acuity From 6 to12 Months

The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12

The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)

The Incidence of Ocular and Non-ocular Adverse Events

Full Information

NCT ID

NCT00498355

First Posted

July 9, 2007

Last Updated

October 24, 2017

Sponsor

University of California, San Francisco

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00498355

Brief Title

Lucentis for Inflammatory Macular Edema Trial

Acronym

LIME

Official Title

Effect of Ranibizumab on Refractory Macular Edema in Uveitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Uveitis is an inflammation (swelling and irritation) inside the eye, affecting the uvea. The uvea is the layer of the eye between the sclera and the retina and provides most of the blood supply to the retina. Uveitis is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis include macular edema, which may persist even when inflammation is controlled. The only current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional steroid injections. For patients who don't respond to steroids or who are unable to tolerate steroid therapy, there are no other medical treatments. The aim of this study is to determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or non-responsive to steroids.

Detailed Description

Uveitis, an inflammation that affects the uvea (iris, ciliary body and choroid), is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis include macular edema, which may persist even when inflammation is controlled. The only current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional steroid injections. For patients who don't respond to steroids or who are unable to tolerate steroid therapy, there are no other medical treatments. The aim of the proposed research is to determine if ranibizumab is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or non-responsive to steroids. Ranibizumab is a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of vascular endothelial growth factor (VEGF). VEGF is suspected to play a role in the loss of vascular integrity in the eye, which is thought to be involved in the pathogenesis of macular edema in the eyes of patients with uveitis. Ranibizumab was approved by the FDA for the treatment of neovascular age-related macular degeneration on June 30, 2006, and a number of published papers have shown efficacy for other causes of macular edema, including that due to diabetes mellitus. The F. I. Proctor Foundation at UCSF will be enrolling 10 subjects 18 years of age or older with uveitis-induced CME to clinically evaluate the safety and effectiveness of ranibizumab administered monthly for three months followed by PRN monthly dosing (up to 12 months). The study will measure visual acuity, changes in foveal thickness on optical coherence tomography, and changes in cystoid macular edema by fluorescein angiography to determine the efficacy of ranibizumab treatment.

6. Conditions and Keywords

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

Uveitis, Cytoid Macular Edema

Keywords

uveitis, cytoid macular edema, steroid, Lucentis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab

Arm Type

Experimental

Arm Description

0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.

Primary Outcome Measure Information:

Title

The Mean Change at 3 Months in BSCVA From Baseline

Description

Time Frame

baseline and 3 months

Secondary Outcome Measure Information:

Title

The Median Change in Best Corrected Visual Acuity From 6 to12 Months

Time Frame

6 to 12 months

Title

The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12

Time Frame

7 days, and at months 3, 6, 9, and 12

Title

The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)

Time Frame

Study duration

Title

The Incidence of Ocular and Non-ocular Adverse Events

Time Frame

Study duration

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 A history of non-infectious uveitis with chronic cystoid macular edema (> 3 months duration) Foveal retinal thickness of ≥ 300 µM by OCT testing One prior trial of oral or regional steroid treatment for CME ≥ 30 days prior to study enrollment with persistent CME (≥ 300 µM foveal retinal thickness on OCT) or inability to use steroid injections due to a history of increased IOP above 30 mmHg thought to be due to topical steroid treatment or prior steroid injections Anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation BCVA at 4 m using the ETDRS chart of 20/40 to 20/400 (Snellen equivalent) in the study eye Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Exclusion Criteria: Pregnancy (positive pregnancy test) or known to be pregnant, or premenopausal but not using adequate contraception Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study. Study subjects will be allowed to continue their immunomodulatory treatment for uveitis throughout the study. Previous vitrectomy Active intraocular inflammation in the study eye (greater than trace anterior chamber or vitreous cells) Current vitreous hemorrhage Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Known allergy to any component of the study drug Intraocular pressure > 30 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 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 Participation in another simultaneous medical investigation or trial Unwilling or unable to follow or comply with all study related procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nisha Acharya, MD MS

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

Proctor Foundation, UCSF

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

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Lucentis for Inflammatory Macular Edema Trial

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