Uveitic Macular Edema
Conditions
Interventions
Vamikibart (Genetical Recombination): Participants will receive 4 low-dose or high-dose RO7200220 intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from
Sponsors
David Silverman
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined protocol. Diagnosis of macular edema associated with non-infectious uveitis (NIU). Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis). BCVA letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
Exclusion criteria
Exclusion criteria: Evidence of active or latent syphilis infection Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis Serious acute or chronic medical illness or psychiatric illness Any major ocular and non-ocular surgical procedure 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 Prior use of any other IVT biologics within 4 months prior to Day 1 Received IVT Methotrexate within 4 months prior to Day 1 Any prior macular foca laser, Cataract surgery within 6 months of Day 1, Laser capsulotomy within 3 months of Day 1 Topical corticosteroids/NSAIDs in the 14 days prior to Day 1, Methylprednisolone intraocular or peri-ocular injection within 2 months prior to Day 1, Dexamethasone (Ozurdex) implant within 4 months prior to Day 1, Fluocinolone acetonide (YUTIQ, ILUVIEN, or Retisert) implant within 3 years prior to Day 1 Diagnosis of macular edema due to any cause other than NIU Any ocular condition that may require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Proportion of participants with greater than or equal to15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Proportion of participants with greater than or equal to 15 letter improvement from baseline in BCVA at Week 20 ( Time Frame: Week 20 ) Change from baseline in BCVA at Week 16 ( Time Frame: Week 16 ) Change from baseline in central subfield thickness (CST) at Week 16 ( Time Frame: Week 16 ) Change from Baseline in BCVA at Weeks 20 and 52 ( Time Frame: Weeks 20 and 52 ) Change from baseline in CST at Weeks 20 and 52 ( Time Frame: Weeks 20 and 52 ) Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold less than 325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52 ( Time Frame: Weeks 16 and 52 ) Time to rescue treatment ( Time Frame: Up to Week 52 ) Number of rescue treatments received ( Time Frame: Up to Week 52 ) Type of rescue treatments received ( Time Frame: Up to Week 52 ) Safety, Efficacy Proportion of participants with greater than or equal to15 letter improvement from baseline in BCVA at Week 16 and 52 ( Time Frame: Weeks 16 and 52 ) Proportion of participants without greater than or equal to15 letter loss from baseline in BCVA at Week 16 and 52 ( Time Frame: Weeks 16 and 52 ) Time to first PRN injection ( Time Frame: Up to Week 52 ) Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 ( Time Frame: Weeks 16 and 52 ) Percentage of participants with ocular adverse events (AEs) ( Time Frame: Up to Week 52 ) Percent change from baseline in corneal endothelial cell density at Week 24 ( Time Frame: Week 24 ) Percentage of participants with non-ocular AEs ( Time Frame: Up to Week 52 ) Percentage of participants with adverse events of special interest (AESIs) ( Time Frame: Up to Week 52 ) Percent change from baseline in corneal endothelial cell density at Week 52 ( Time Frame: Week 52 ) Phamacokinetics, Other Aqueous humor (AH) concentration of RO7200200 ( Time Frame: | — |
Countries
ARGENTINA, AUSTRALIA, CANADA, CZECH REPUBLIC, FRANCE, GERMANY, INDIA, Japan, SINGAPORE, SPAIN, SWITZERLAND, TURKIYE, UNITED STATES
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed