Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | June 2008 |
| End Date: | July 2010 |
| Contact: | Thomas A Albini, MD |
| Email: | talbini@med.miami.edu |
| Phone: | 305-482-5006 |
Uveitic CME is a major cause of visual loss associated with uveitis. Systemic and/or local
corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as
cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and
associated CME in many patients. However, in many cases, CME persists in spite of adequate
suppression of uveitis. No consensus exists on how best to treat such cases. The further
addition of immunosuppressive agents appears to have little effect on this form of CME.
Oral corticosteroids are useful, but high dosage and prolonged use can be associated with
serious side-effects. Periocular and intravitreal corticosteroid injections are associated
with well-known, significant side effects such as glaucoma and cataract formation.
Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of
vascular integrity in the eye and known to be induced by inflammatory cytokines, such as
interleukin IL-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it
has been demonstrated that aqueous VEGF concentrations are statistically significantly
higher in those uveitis patients with CME than those without CME. Inhibition of
inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our
current knowledge of the pathophysiology of this condition and also because of the clinical
need for additional treatment options for these patients. Ranibizumab, a recombinant,
humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active
forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in
uveitis patients.
The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and
effective in leading to regression of macular edema due to chronic non-infectious uveitis in
patients with well-controlled uveitis.
corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as
cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and
associated CME in many patients. However, in many cases, CME persists in spite of adequate
suppression of uveitis. No consensus exists on how best to treat such cases. The further
addition of immunosuppressive agents appears to have little effect on this form of CME.
Oral corticosteroids are useful, but high dosage and prolonged use can be associated with
serious side-effects. Periocular and intravitreal corticosteroid injections are associated
with well-known, significant side effects such as glaucoma and cataract formation.
Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of
vascular integrity in the eye and known to be induced by inflammatory cytokines, such as
interleukin IL-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it
has been demonstrated that aqueous VEGF concentrations are statistically significantly
higher in those uveitis patients with CME than those without CME. Inhibition of
inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our
current knowledge of the pathophysiology of this condition and also because of the clinical
need for additional treatment options for these patients. Ranibizumab, a recombinant,
humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active
forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in
uveitis patients.
The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and
effective in leading to regression of macular edema due to chronic non-infectious uveitis in
patients with well-controlled uveitis.
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
1. Ability to provide written informed consent and comply with study assessments for the
full duration of the study.
2. Age > 18 years
3. Non-infectious uveitis in study eye.
4. Stable anti-uveitis medical regimen for at least one month prior to injection and
controlled uveitis in the judgment of the investigator.
5. Vision 20/40 or worse in study eye.
6. Cystoid Macular Edema (CME) on fluorescein angiography (FA)
7. Optical Coherence Tomography (OCT) demonstrating thickness greater than 300 microns
in the central subfield.
8. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT
testing and retinal photography.
Only one eye will be assessed in the study. If both eyes are eligible, the investigator
will determine which eye will be entered into the study.
Exclusion Criteria:
1. Previous intravitreal triamcinolone injection in study eye within 3 months of study
injection.
2. Use of more than two glaucoma medicines for study eye.
3. Significant epiretinal membrane as judged by treating physician.
4. Evidence of vitreomacular traction on OCT.
5. Previous vitrectomy in study eye.
6. Pregnancy (positive pregnancy test) or lactation.
7. Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
8. Any other condition that the investigator believes would pose a significant hazard
to the subject if the investigational therapy were initiated.
9. Participation in another simultaneous IND trial.
10. Treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks
prior to enrollment in this study.
11. Uncontrolled inflammation in the study eye.
12. Current vitreous hemorrhage.
13. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either
eye.
14. Known allergy to any component of the study drug.
15. Intraocular pressure > 25 mm Hg despite treatment with glaucoma medications.
16. 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.
17. Major non-ocular surgery planned during the next 6 months.
18. Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated.
19. No Avastin use permitted in fellow eye during study.
20. Unwilling or unable to follow or comply with all study related procedures
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