Uveitis Related Cystoid Macular Edema Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05608837 -
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
|
Phase 2 | |
| Completed |
NCT01299129 -
Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema
|
N/A |