Phase 2
N=7
Lucentis for Inflammatory Macular Edema Trial
Uveitis · Cytoid Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00498355 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: The Mean Change at 3 Months in BSCVA From Baseline — 13 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change at 3 Months in BSCVA From Baseline |
13 | — |
| SECONDARY The Median Change in Best Corrected Visual Acuity From 6 to12 Months |
-2 | — |
| SECONDARY The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 |
-267; -356; -354; -243; -388 | — |
| SECONDARY The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous) |
— | — |
| SECONDARY The Incidence of Ocular and Non-ocular Adverse Events |
4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00498355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.