RO7200220 in Participants With Uveitic Macular Edema

JRCT ID: jRCT2051220203

Registered date:31/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Uveitic Macular Edema
• Date of first enrollment: 30/06/2023
• Target sample size: 225
• Countries of recruitment: UNITED STATES,Japan,AUSTRALIA,Japan,CANADA,Japan,FRANCE,Japan,GERMANY,Japan,SPAIN,Japan,ARGENTINA,Japan,CZECH REPUBLIC,Japan,SWITZERLAND,Japan,TURKIYE,Japan,INDIA,Japan,SINGAPORE,Japan
• Study type: Interventional
• Intervention(s): RO7200220: 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 Week 20 to Week 48

Outcome(s)

Primary Outcome

Efficacy
Proportion of participants with greater than or equal to15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16

Secondary Outcome

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: Up to Week 52 )
Serum concentration of RO7200220 ( Time Frame: Up to Week 52 )
Anti-drug antibody titer to RO7200220 ( Time Frame: Baseline to Week 52 )

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: David Silverman
• Secondary ID(s): NCT05642325