SANDCAT

Actively Recruiting // Clinical Trials // Laura Kopplin // Uveitic Macular Edema // Uveitis // Jan 23 2023

A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients with Uveitic Macular Edema (Sandcat)

  • Sponsor: Hoffmann-La Roche
  • Principal Investigator: Laura Kopplin, MD
  • Study Coordinator: Kelly Boyd

Study Objective:

To assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.

Study Design:

Participants will be randomized 1:1:1 to receive four RO7200220 1.0 mg intravitreal injections until week 12 followed by as needed dosing, four RO7200220 0.25 mg intravitreal injections until week 12 followed by as needed dosing or four sham injections until week 12 followed by as needed sham dosing. Total study duration is approximately 52 weeks.

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
  • Diagnosis of active or inactive, acute, or chronic non-infectious uveitis of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
  • BCVA letter score of 73 to 19 letters on Early Treatment Diabetic Retinopathy Study (EDTRS)

Exclusion Criteria:

  • Evidence of active or latent syphilis infection
  • Evidence of active or latent tuberculosis infection, or previous or current HIV diagnosis
  • 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 IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; prior or concomitant use of IVT Methotrexate
  • 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 in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
  • Diagnosis of macular edema due to any cause other than non-infectious uveitis

Contact Kelly Boyd with questions, (608) 265-4589

For more information about this study, visit clinicaltrials.gov: RO7200220 in Participants With Uveitic Macular Edema – Full Text View – ClinicalTrials.gov