A Study to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Adult and Pediatric Patients with Uveitic Macular Edema
- Conditions
- veitic Macular EdemaTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2022-501793-19-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 225
Diagnosis of macular edema associated with non-infectious uveitis (NIU) defined as macular thickening by spectral-domain optical coherence tomography (SD-OCT) involving the center of the macula at screening, Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) based on investigator assessment, Best corrected visual acuity (BCVA) letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts (20/40 – 20/400 Snellen equivalent) on Day 1 based on the assessment at study site
Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, syphilis infection, or previous or current HIV diagnosis, based on investigator’s assessment of clinical laboratory tests or physical examination, Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss or likely contribute to worsening vision over the study period or preclude any visual improvement due to established structural damage or difficulty interpretation of the study results, Serious acute or chronic medical or psychiatric illness or abnormality in clinical laboratory tests or physical examination that would preclude participation in the study, History of major non-ocular surgical procedures within 1 month prior to Day 1., Uncontrolled IOP or glaucoma or chronic hypotony, Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images as assessed by the investigator, Prior use of IVT biologics including anti-VEGFs within 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1., Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1, Any topical ocular corticosteroid/NSAIDs in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant within 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant within 3 years prior to D1, Diagnosis of macular edema due to any cause other than NIU as assessed by the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of RO7200220 on functional outcomes compared with sham;Secondary Objective: To evaluate the efficacy of RO7200220 on functional outcomes compared with sham, To evaluate the efficacy of RO7200220 on the mean functional outcomes compared with sham, To evaluate the efficacy of RO7200220 on the mean anatomical outcomes compared with sham, To evaluate the safety of RO7200220 compared with sham, To evaluate the safety of RO7200220 in study eye compared with fellow eye, To characterize pharmacokinetics of RO7200220, To characterize the aqueous humor pharmacodynamics (IL-6), To investigate the formation of serum ADAs, To evaluate potential effects of serum ADAs, To evaluate the efficacy of RO7200220 on additional functional, anatomical, and participant-reported outcomes compared with sham;Primary end point(s): 1. Proportion of participants with =15 letter improvement from baseline in BCVA at Week 16
- Secondary Outcome Measures
Name Time Method