Sandcat: RO7200220 in Participants With Uveitic Macular Edema
Study Details
Study Description
Brief Summary
This study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A Participants will receive 4 low-dose RO7200220 intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48. |
Drug: RO7200220
Participants will receive RO7200220 IVT injection
|
| Experimental: Arm B Participants will receive 4 high-dose RO7200220 IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. |
Drug: RO7200220
Participants will receive RO7200220 IVT injection
|
| Sham Comparator: Arm C Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. |
Other: Sham
Participants will receive a sham procedure that mimics an IVT injection.
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 [Week 16]
Secondary Outcome Measures
- Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20 [Week 20]
- Change from baseline in BCVA at Week 16 [Week 16]
- Change from baseline in central subfield thickness (CST) at Week 16 [Week 16]
- Change from Baseline in BCVA at Weeks 20 and 52 [Weeks 20 and 52]
- Change from baseline in CST at Weeks 20 and 52 [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 <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52 [Weeks 16 and 52]
- Time to rescue treatment [Up to Week 52]
- Number of rescue treatments received [Up to Week 52]
- Type of rescue treatments received [Up to Week 52]
- Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52 [Weeks 16 and 52]
- Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52 [Weeks 16 and 52]
- Time to first PRN injection [Up to Week 52]
- Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 [Weeks 16 and 52]
- Percentage of participants with ocular adverse events (AEs) [Up to Week 52]
- Percent change from baseline in corneal endothelial cell density at Week 24 [Week 24]
- Percentage of participants with non-ocular AEs [Up to Week 52]
- Percentage of participants with adverse events of special interest (AESIs) [Up to Week 52]
- Percent change from baseline in corneal endothelial cell density at Week 52 [Week 52]
- Aqueous humor (AH) concentration of RO7200200 [Up to Week 52]
- Serum concentration of RO7200220 [Up to Week 52]
- Anti-drug antibody titer to RO7200220 [Baseline to Week 52]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the 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 (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
Exclusion Criteria:
-
Evidence of active or latent syphilis infection
-
Evidence of active or latent tuberculosis infection, or previous or current HIV diagnosis
-
Serious acute or chronic medical or psychiatric illness
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History of major ocular and non-ocular surgical procedures
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Uncontrolled IOP or glaucoma or chronic hypotony
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Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
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Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; prior or concomitant use of IVT Methotrexate
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Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
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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 in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
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Diagnosis of macular edema due to any cause other than NIU
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Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istanbul University Cerrahpasa Faculty of Medicine | Istanbul | Turkey | 34098 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-LaRoche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GR44278