RO7200220 in Participants With Uveitic Macular Edema (Sandcat)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    225
  • sponsor
    Hoffmann-La Roche
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Updated on 20 September 2023
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Summary

This study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.

Details
Condition Uveitic Macular Edema
Treatment SHAM, RO7200220
Clinical Study IdentifierNCT05642325
SponsorHoffmann-La Roche
Last Modified on20 September 2023

Eligibility

 Yes No Not Sure

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 and/or positive tuberculosis assay, or previous or current HIV diagnosis
Serious acute or chronic medical or psychiatric illness
History of major ocular and non-ocular surgical procedures
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; 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
Topical corticosteroids and/or topical NSAID > 3 drops per day 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 NIU
Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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