UveitisPhase 1/2LIMENCT00498355
Lucentis for Inflammatory Macular Edema Trial
A Phase 1/2 study testing Ranibizumab in people with Uveitis and Cytoid Macular Edema, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Cytoid Macular Edema
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Proctor Foundation, UCSF
San Francisco, California, 94143
About this study
Official title: Effect of Ranibizumab on Refractory Macular Edema in Uveitis
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.
Read the 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.
- Conditions
- Uveitis, Cytoid Macular Edema
- Being tested
- Ranibizumab
- Keywords
- uveitis, cytoid macular edema, steroid, Lucentis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
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.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | 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. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 months
Secondary outcomes (4)
The Median Change in Best Corrected Visual Acuity From 6 to12 Months
Measured: 6 to 12 months
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12
Measured: 7 days, and at months 3, 6, 9, and 12
The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)
Measured: Study duration
The Incidence of Ocular and Non-ocular Adverse Events
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Nisha Acharya, MD MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498355
- Sponsor's protocol ID
- FVF3872s
- Acronym
- LIME
- Status last verified
- Oct 2017
- First submitted
- 9 Jul 2007
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ranibizumab on Refractory Macular Edema in Uveitis
- ClinicalTrials.gov ID
- NCT00498355
- Acronym / sponsor ID
- LIME / FVF3872s
- Conditions
- Uveitis, Cytoid Macular Edema
- Keywords
- uveitis, cytoid macular edema, steroid, Lucentis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Jul 2007 (estimated)
- Results
- Posted 21 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab0.5 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanibizumabAlso: Lucentis0.5 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. | Drug | Ranibizumab |
Primary outcome
The Mean Change at 3 Months in BSCVA From Baseline
Time frame: baseline and 3 months
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.
4 secondary outcomes
The Median Change in Best Corrected Visual Acuity From 6 to12 Months
Time frame: 6 to 12 months
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
The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)
Time frame: Study duration
The Incidence of Ocular and Non-ocular Adverse Events
Time frame: Study duration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisha Acharya, MD MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ranibizumab in people with Uveitis and Cytoid Macular Edema, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mean Change at 3 Months in BSCVA From Baseline (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.