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A Study to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients with Uveitic Macular Edema
EU CTIS ID: 2022-501793-19-00
What this study is testing
To evaluate the efficacy of RO7200220 on best corrected visual acuity (BCVA) functional outcome compared with sham
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of macular edema associated with non‑infectious uveitis (NIU) defined as macular thickening by spectral‑domain optical coherence tomography (SD‑OCT) involving the center of the macula confirmed by central reading center with CST >/=325 μm with Spectralis (>/=315 μm with Cirrus or Topcon) at screening.
- Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) based on investigator assessment
- Best corrected visual acuity (BCVA) letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)‑like charts (20/40 – 20/400 Snellen equivalent) on Day 1 based on the assessment at study site
You likely can't join if
- Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, syphilis infection, or previous or current HIV diagnosis, based on investigator’s assessment of clinical laboratory tests or physical examination
- Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss or likely contribute to worsening vision over the study period or preclude any visual improvement due to established structural damage or difficulty interpretation of the study results
- Serious acute or chronic medical (e.g., malignancy, metabolic dysfunction, renal failure, uncontrolled hypertension, etc.) or psychiatric illness or abnormality in clinical laboratory tests or physical examination that would preclude participation in the study
- History of major non‑ocular surgical procedures within 1 month prior to Day 1.
- 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 as assessed by the investigator
See the full eligibility criteria
- Diagnosis of macular edema associated with non‑infectious uveitis (NIU) defined as macular thickening by spectral‑domain optical coherence tomography (SD‑OCT) involving the center of the macula confirmed by central reading center with CST >/=325 μm with Spectralis (>/=315 μm with Cirrus or Topcon) at screening.
- Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) based on investigator assessment
- Best corrected visual acuity (BCVA) letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)‑like charts (20/40 – 20/400 Snellen equivalent) on Day 1 based on the assessment at study site
- Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, syphilis infection, or previous or current HIV diagnosis, based on investigator’s assessment of clinical laboratory tests or physical examination
- Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss or likely contribute to worsening vision over the study period or preclude any visual improvement due to established structural damage or difficulty interpretation of the study results
- Serious acute or chronic medical (e.g., malignancy, metabolic dysfunction, renal failure, uncontrolled hypertension, etc.) or psychiatric illness or abnormality in clinical laboratory tests or physical examination that would preclude participation in the study
- History of major non‑ocular surgical procedures within 1 month prior to Day 1.
- 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 as assessed by the investigator
- Prior use of IVT anti-VEGFs and any other IVT biologics within 2 and -4 months prior to Day 1 respectively; 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
- Any topical ocular corticosteroid/NSAIDs > 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 within 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant within 3 years prior to D1
- Diagnosis of macular edema due to any cause other than NIU as assessed by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Korea, Republic of
- Mexico
- Taiwan
- Israel
- Brazil
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Korea, Republic of; Mexico; Taiwan; Israel; Brazil and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.