All > Macular Edema > Paid Studies Austin

Arm A for Uveitic Macular Edema

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Austin Clinical Research LLC, Austin, TXUveitic Macular EdemaRO7200220 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a new drug to treat swelling in the back of the eye that can cause vision loss.

Eligible Conditions
  • Uveitic Macular Edema

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Episcleral Celecoxib
1
Patients with Diabetic Macular Edema
1
Active treatment arm: OCS-01 (dexamethasone)

Study Objectives

1 Primary · 22 Secondary · Reporting Duration: Weeks 20 and 52

Baseline to Week 52
Anti-drug antibody titer to RO7200220
Up to Week 52
Aqueous humor (AH) concentration of RO7200200
Number of PRN injections received
Number of rescue treatments received
Percentage of participants with adverse events of special interest (AESIs)
Percentage of participants with non-ocular AEs
Percentage of participants with ocular adverse events (AEs)
Serum concentration of RO7200220
Time to first PRN injection
Time to rescue treatment
Type of rescue treatments received
Week 16
Change from baseline in BCVA at Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Week 20
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Week 24
Percent change from baseline in corneal endothelial cell density at Week 24
Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Weeks 16 and 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 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
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Weeks 20 and 52
Change from Baseline in BCVA at Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Episcleral Celecoxib
1
Patients with Diabetic Macular Edema
2
Active treatment arm: OCS-01 (dexamethasone)

Trial Design

3 Treatment Groups

Arm A
1 of 3
Arm B
1 of 3
Arm C
1 of 3

Experimental Treatment

Non-Treatment Group

225 Total Participants · 3 Treatment Groups

Primary Treatment: Arm A · Has Placebo Group · Phase 3

Arm A
Drug
Experimental Group · 1 Intervention: RO7200220 · Intervention Types: Drug
Arm B
Drug
Experimental Group · 1 Intervention: RO7200220 · Intervention Types: Drug
Arm C
Other
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 20 and 52

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,374 Previous Clinical Trials
1,068,689 Total Patients Enrolled
1 Trials studying Uveitic Macular Edema
225 Patients Enrolled for Uveitic Macular Edema
Clinical TrialsStudy DirectorHoffmann-La Roche
2,155 Previous Clinical Trials
876,565 Total Patients Enrolled
1 Trials studying Uveitic Macular Edema
225 Patients Enrolled for Uveitic Macular Edema

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have swelling in the center of your retina caused by non-infectious uveitis.
You have any type of uveitis, which is an inflammation of the eye.
References

Frequently Asked Questions

To what extent can Arm A pose a hazard to people?

"The risk profile of Arm A was assessed as a 3, stemming from the Phase 3 trial status and evidence-based corroboration that its efficacy is supported by sufficient data." - Anonymous Online Contributor

Unverified Answer

Does this research project presently require participants?

"Clinicaltrials.gov indicates that this investigation is actively seeking participants; the initial advertisement was published on January 13th 2023 and was last revised on January 6th 2023." - Anonymous Online Contributor

Unverified Answer

What is the cap on the number of participants in this experiment?

"Hoffmann-La Roche is overseeing the trial from Erie Retinal Surgery in Pennsylvania and Texas Retina Associates in Dallas. The experiment necessitates 225 qualified participants to commence." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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