Uveitis Related Cystoid Macular EdemaPhase 2NCT01564108
The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema
A Phase 2 study testing Ranibizumab in people with Uveitis Related Cystoid Macular Edema and Steroid-induced Glaucoma - Borderline, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment of a variety of retinal diseases. This study addresses a condition which affects a large number of our patients in whom the investigators face difficult management decisions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uveitis Related Cystoid Macular Edema, Steroid-induced Glaucoma - Borderline
- 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
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cystoid macular oedema (CMO) from non-infectious uveitis:
- Unilateral or Bilateral CMO (the worse eye only will be treated with intravitreal Ranibizumab) in a quiet eye for 1month.
- On clinical exam and OCT, definite retinal thickening due to uveitic macular oedema involving the centre of the macula, refractory or ineligible for standard care.
- Spectralis SD-OCT central subfield >=270 μm within 10 working days of study entry with uveitic macular oedema (cystoid or diffuse).
- Quiet eye
- as defined by 0-0.5 plus of cells in anterior chamber of the eye, and 0.5 or less vitreous haze (SUN classification).
Show all 10Show fewer
- topical / systemic immunosuppressive treatment allowed but stable for 2 month with no resolution of CMO in a quiet eye for 1 month.
- greater than 3 months since orbital steroid injection, 4 months since intravitreal triamcinolone treatment, or 8 weeks since starting new oral therapy
- at least 1 prior trial of oral, orbital or intravitreal steroid therapy for CMO or not eligible for steroid treatment (oral, orbital or intravitreal steroid) because IOP > 30 mmHg following such use in study eye or fellow eye (i.e. patient is a known steroid responder), at any time in the past.
- Best corrected visual acuity in the study eye must be between 69 and 35 ETDRS letter score at 4m (Snellen equivalent of 6/12-6/60) within 10 working days of enrolment.
Who cannot join
- Other causes of macular oedema e.g. diabetic macular oedema etc.
- Presence of an ocular disease that in the opinion of the investigator is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates).
- Evidence of irreversible central visual loss
- Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT.
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).
- History of cataract surgery within prior 6 months or cataract surgery anticipated within 6 months of starting the trial.
Show all 10Show fewer
- Any anti-VEGF treatment to study eye within 4 months.
- Uncontrolled IOP > = 24 mmHg (on topical IOP lowering medications).
- History of glaucoma.
- Patients with active or suspected ocular or periocular infections
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHSFT Research and Treatment Centre
London, EC1V 2PD
About this study
Official title: An Exploratory Study of Ranibizumab (Lucentis) for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema Which Has Proven Refractory or Ineligible to Standard Treatment.
Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment of a variety of retinal diseases. This study addresses a condition which affects a large number of our patients in whom the investigators face difficult management decisions. These patients with uveitis are severely disabled with visual loss related to cystoid macular oedema (CMO) and few options remain when standard treatment has either failed or is contraindicated.
The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be more effective in improving quality of life by reducing macular thickening and restoring visual function.
Read the detailed description
The study has been designed as an open label, prospective non-randomised interventional case series.
Clinical staff will be asked to briefly discuss the option of enrolling into the study with potentially suitable patients. If the patient expresses an interest in finding out more about the study, the doctor will then contact a member of the study team, who will provide the patient with the patient information leaflet. This outlines the details and purpose of the study, the intended benefits of the intravitreal treatment and the potential hazards (including the unlicensed use of Ranibizumab for this indication). The intravitreal injection procedure will be discussed. The follow-up schedule will be outlined. There will be an opportunity for the patient to ask questions and at least 24 hours for the patient to think about entering the study. Only 1 eye of each patient, the worse eye, will be enrolled.
Comprehensive pre- and post- therapy and a longitudinal series of structure and function tests will be performed on all 20 enrolled patients. All patients will receive intravitreal injections performed in a designated clean room. The injections (Ranibizumab 0.5 mg in 0.05 ml) will be administered 4-5 weekly, for three injections then according to clinical need for a total of 12 months of follow-up. A maximum of 5 intravitreal Ranibizumab injections will be administered to patients who do not demonstrate any positive clinical response.
The patients will be seen for baseline screening over a 2 day period, with the first treatment with Ranibizumab administered on the second day (maximum of 10 working days after the first baseline screening day). Subsequent to the first 3 injections, the investigator will assess whether re-treatment is warranted (clinical / OCT criteria set out in re-treatment protocol). Re-treatment, when indicated, will be performed on the same day as the follow-up visit and no sooner than 4 weeks or later than 5 weeks from the time of the last treatment. If re-treatment with IVI Ranibizumab is to be deferred patients will not be given a sham injection. Should a relapse in ocular inflammation occur, it might be difficult to differentiate as to whether this is because of the drug or the underlying disease. A mild flare up, Lucentis-related or not, may be observed and treated with topical therapy (but patient will remain in the study). A moderate to severe recurrence, regardless of the cause which will necessitate more extensive therapy, namely a change or addition of systemic therapy, will result in the patient exiting the study-this would be an end point.
- Being tested
- Ranibizumab
- Keywords
- Intravitreal Ranibizumab, Non-infectious uveitis, Refractory Cystoid Macular Oedema, Lucentis, LIMO
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Series of intravitreal injections of Ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Series of intravitreal injections of Ranibizumab Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients in whom, by consensus, no further treatment is required.
Intravitreal Ranibizumab will be given at baseline, month 1 and month 2 . Subsequent 4-5 weekly injections will be given according to clinical need. There will be a total of 12 months of follow-up.
Measured: Data will be collected at every patient visit which will take place every 4-5 weeks, and analysed at 12 months follow-up
Change in CRT as measured by Spectralis spectral domain OCT.
Measured: at baseline visit then at 6 and 12 months.
Secondary outcomes (12)
Functional vision changes based on self-reported quality of life measures (including acceptability of 4 weekly intravitreal therapy).
Measured: at baseline visit then at 6 and 12 months.
The proportion of subjects gaining >10 and >15 letters.
Measured: at baseline vist, on day 7 and day 14, then on monthly basis.
Change in contrast sensitivity.
Measured: at baseline visit then at months 1, 3, 6, 9 and 12.
Change in BCVA.
Measured: at baseline visit then at 3, 6, 9 and 12 months.
The proportion of subjects with loss of >15 letters and >30 letters.
Measured: at baseline vist, on day 7 and day 14, then on monthly basis.
Change in retinal sensitivity on microperimetry.
Measured: at baseline visit then on month 3, 6, 9 and 12.
Change in reading speed.
Measured: at baseline visit, months 1, 3,6, 9 and 12.
Evidence of improvement in PERG or mfERG.
Measured: at baseline visit, month 4, and 12.
Maintenance of the foveal avascular zone.
Measured: at baseline, 6 and 12.
Absence of toxicity on Electrophysiological testing / microperimetry / autofluorescence.
Measured: at baseline visit then on month 3, 4,6, 9 and 12.
Incidence and severity of ocular adverse events.
Measured: at day 7, day 14, month 1 then every month until 12 month post initial intravitreal injection
Incidence and severity of non ocular adverse events.
Measured: at day 7, day 14, month 1 then every month until 12 month post initial intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study start1 May 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis Related Cystoid Macular EdemaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Narciss Okhravi, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564108
- Sponsor's protocol ID
- OKHN1005
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2012
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Ranibizumab (Lucentis) for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema Which Has Proven Refractory or Ineligible to Standard Treatment.
- ClinicalTrials.gov ID
- NCT01564108
- Acronym / sponsor ID
- OKHN1005
- Keywords
- Intravitreal Ranibizumab, Non-infectious uveitis, Refractory Cystoid Macular Oedema, Lucentis, LIMO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 May 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment of a variety of retinal diseases. This study addresses a condition which affects a large number of our patients in whom the investigators face difficult management decisions. These patients with uveitis are severely disabled with visual loss related to cystoid macular oedema (CMO) and few options remain when standard treatment has either failed or is contraindicated.
The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be more effective in improving quality of life by reducing macular thickening and restoring visual function.
Detailed description
The study has been designed as an open label, prospective non-randomised interventional case series.
Clinical staff will be asked to briefly discuss the option of enrolling into the study with potentially suitable patients. If the patient expresses an interest in finding out more about the study, the doctor will then contact a member of the study team, who will provide the patient with the patient information leaflet. This outlines the details and purpose of the study, the intended benefits of the intravitreal treatment and the potential hazards (including the unlicensed use of Ranibizumab for this indication). The intravitreal injection procedure will be discussed. The follow-up schedule will be outlined. There will be an opportunity for the patient to ask questions and at least 24 hours for the patient to think about entering the study. Only 1 eye of each patient, the worse eye, will be enrolled.
Comprehensive pre- and post- therapy and a longitudinal series of structure and function tests will be performed on all 20 enrolled patients. All patients will receive intravitreal injections performed in a designated clean room. The injections (Ranibizumab 0.5 mg in 0.05 ml) will be administered 4-5 weekly, for three injections then according to clinical need for a total of 12 months of follow-up. A maximum of 5 intravitreal Ranibizumab injections will be administered to patients who do not demonstrate any positive clinical response.
The patients will be seen for baseline screening over a 2 day period, with the first treatment with Ranibizumab administered on the second day (maximum of 10 working days after the first baseline screening day). Subsequent to the first 3 injections, the investigator will assess whether re-treatment is warranted (clinical / OCT criteria set out in re-treatment protocol). Re-treatment, when indicated, will be performed on the same day as the follow-up visit and no sooner than 4 weeks or later than 5 weeks from the time of the last treatment. If re-treatment with IVI Ranibizumab is to be deferred patients will not be given a sham injection. Should a relapse in ocular inflammation occur, it might be difficult to differentiate as to whether this is because of the drug or the underlying disease. A mild flare up, Lucentis-related or not, may be observed and treated with topical therapy (but patient will remain in the study). A moderate to severe recurrence, regardless of the cause which will necessitate more extensive therapy, namely a change or addition of systemic therapy, will result in the patient exiting the study-this would be an end point.
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: RanibizumabSeries of intravitreal injections of Ranibizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cystoid macular oedema (CMO) from non-infectious uveitis:
- Best corrected visual acuity in the study eye must be between 69 and 35 ETDRS letter score at 4m (Snellen equivalent of 6/12-6/60) within 10 working days of enrolment.
Key exclusion criteria (10 listed)
- Other causes of macular oedema e.g. diabetic macular oedema etc.
- Presence of an ocular disease that in the opinion of the investigator is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates).
- Evidence of irreversible central visual loss
- Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT.
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).
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: LucentisSeries of intravitreal injections of Ranibizumab | Drug | Ranibizumab |
Primary outcome
The number of patients in whom, by consensus, no further treatment is required.
Time frame: Data will be collected at every patient visit which will take place every 4-5 weeks, and analysed at 12 months follow-up
Intravitreal Ranibizumab will be given at baseline, month 1 and month 2 . Subsequent 4-5 weekly injections will be given according to clinical need. There will be a total of 12 months of follow-up.
Change in CRT as measured by Spectralis spectral domain OCT.
Time frame: at baseline visit then at 6 and 12 months.
12 secondary outcomes
Functional vision changes based on self-reported quality of life measures (including acceptability of 4 weekly intravitreal therapy).
Time frame: at baseline visit then at 6 and 12 months.
The proportion of subjects gaining >10 and >15 letters.
Time frame: at baseline vist, on day 7 and day 14, then on monthly basis.
Change in contrast sensitivity.
Time frame: at baseline visit then at months 1, 3, 6, 9 and 12.
Change in BCVA.
Time frame: at baseline visit then at 3, 6, 9 and 12 months.
The proportion of subjects with loss of >15 letters and >30 letters.
Time frame: at baseline vist, on day 7 and day 14, then on monthly basis.
Change in retinal sensitivity on microperimetry.
Time frame: at baseline visit then on month 3, 6, 9 and 12.
Change in reading speed.
Time frame: at baseline visit, months 1, 3,6, 9 and 12.
Evidence of improvement in PERG or mfERG.
Time frame: at baseline visit, month 4, and 12.
Maintenance of the foveal avascular zone.
Time frame: at baseline, 6 and 12.
Absence of toxicity on Electrophysiological testing / microperimetry / autofluorescence.
Time frame: at baseline visit then on month 3, 4,6, 9 and 12.
Incidence and severity of ocular adverse events.
Time frame: at day 7, day 14, month 1 then every month until 12 month post initial intravitreal injection
Incidence and severity of non ocular adverse events.
Time frame: at day 7, day 14, month 1 then every month until 12 month post initial intravitreal injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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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.
Narciss Okhravi principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab in people with Uveitis Related Cystoid Macular Edema and Steroid-induced Glaucoma - Borderline, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 10 inclusion and 10 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 27 Mar 2019. 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 Kingdom. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 number of patients in whom, by consensus, no further treatment is required. (time frame: Data will be collected at every patient visit which will take place every 4-5 weeks, and analysed at 12 months follow-up). The study lists 2 primary outcomes in all. 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 27 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.