RO7250284 for Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Macular Degeneration
RO7250284 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for age-related macular degeneration given through injections in the eye and via a delivery system. They are testing how safe and effective it is.

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

20 Primary · 11 Secondary · Reporting Duration: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9.

Week 144
Change from Baseline Over Time in CST
Change from Baseline Over Time in Center Point Thickness (CPT)
Month 12
Duration of Ocular Adverse Events of Special Interest (AESIs)
Percentage of Participants with Ocular Adverse Events of Special Interest (AESIs)
Month 12
Duration of Adverse Events of Special Interest (AESIs) including Ocular AESIs
Duration of Adverse Events of Special Interest (AESIs) including Ocular AESIs during the Postoperative and Follow-up periods
Percentage of Participants with Ocular and Systemic (Nonocular) Adverse Events
Week 144
Area Under the Curve (AUC) of RO7250284 in Blood and AH
Concentration at the End of a Dosing Interval before the Next Dose Administration (Ctrough) of RO7250284 in Blood and AH
Maximum Observed Concentration (Cmax) of RO7250284 in Blood and Aqueous Humor (AH)
Time of Maximum Concentration Observed (Tmax) of RO7250284 in Blood and AH
Week 48
Duration of AESIs including Ocular AESIs
Percentage of Participants with Adverse Events of Special Interest (AESIs) including Ocular AESIs
Percentage of Participants with Ocular and Systemic (Nonocular) Adverse Events (AEs)
Week 48
Fluorophotometry
Percentage of Participants with AESIs including Ocular AESIs during the Postoperative and Follow-up periods
Percentage of Participants with Ocular and Systemic (Nonocular) AEs during Post-operative and Follow-up Periods
Week 48
Percentage of Participants with Adverse Events of Special Interest (AESIs) including Ocular AESIs during the Postoperative and Follow-up periods
Week 48
Duration of ADEs
Duration of ASADEs
Duration of Adverse Device Effects (ADEs)
Duration of Anticipated Serious ADEs (ASADEs)
Percentage of Participants with ASADEs
Percentage of Participants with Adverse Device Effects (ADEs)
Percentage of Participants with Anticipated Serious ADEs (ASADEs)
Week 48
Change from Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score
Week 48
Change from Baseline in Center Point Thickness (CPT)
Change from Baseline in Central Subfield Thickness (CST)
Percentage of Participants who Gain or Lose ≥15, ≥10 or ≥5 letters in ETDRS-BCVA score from Baseline
Percentage of Participants who Gained or Lost ≥15, ≥10 ≥5 or ≥0 letters in ETDRS-BCVA score from Baseline
Week 44
Percentage of Participants who did not meet Supplemental Treatment Criteria for the PDS implant with RO7250284

Trial Safety

Safety Progress

1 of 3

Trial Design

10 Treatment Groups

Part 3: Port Delivery with Ranibizumab
1 of 10
Part 3: Port Delivery System with Ranibizumab
1 of 10
Part 2: Port Delivery System with Low Dose
1 of 10
Part 2: Port Delivery System with High Dose
1 of 10
Part 3: Port Delivery with High Dose
1 of 10
Part 2: Port Delivery with High Dose
1 of 10
Part 3: Port Delivery with Low Dose
1 of 10
Part 1: Intravitreal Injections
1 of 10
Part 2: Port Delivery with Low Dose
1 of 10
Part 3: Port Delivery System with High Dose
1 of 10

Active Control

Experimental Treatment

251 Total Participants · 10 Treatment Groups

Primary Treatment: RO7250284 · No Placebo Group · Phase 1

Part 2: Port Delivery System with Low Dose
Drug
Experimental Group · 1 Intervention: RO7250284 · Intervention Types: Drug
Part 2: Port Delivery System with High Dose
Drug
Experimental Group · 1 Intervention: RO7250284 · Intervention Types: Drug
Part 3: Port Delivery with High DoseExperimental Group · 2 Interventions: RO7250284, Port Delivery Platform · Intervention Types: Drug, Device
Part 2: Port Delivery with High DoseExperimental Group · 2 Interventions: RO7250284, Port Delivery Platform · Intervention Types: Drug, Device
Part 3: Port Delivery with Low DoseExperimental Group · 2 Interventions: RO7250284, Port Delivery Platform · Intervention Types: Drug, Device
Part 1: Intravitreal Injections
Drug
Experimental Group · 1 Intervention: RO7250284 · Intervention Types: Drug
Part 2: Port Delivery with Low DoseExperimental Group · 2 Interventions: RO7250284, Port Delivery Platform · Intervention Types: Drug, Device
Part 3: Port Delivery System with High Dose
Drug
Experimental Group · 1 Intervention: RO7250284 · Intervention Types: Drug
Part 3: Port Delivery with RanibizumabActiveComparator Group · 2 Interventions: Port Delivery Platform, Ranibizumab · Intervention Types: Device, Drug
Part 3: Port Delivery System with Ranibizumab
Drug
ActiveComparator Group · 1 Intervention: Ranibizumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: part 1: baseline up to week 24; part 2: baseline up to month 12; part 3: baseline up to month 9.

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,353 Previous Clinical Trials
1,093,857 Total Patients Enrolled
22 Trials studying Macular Degeneration
14,548 Patients Enrolled for Macular Degeneration
Clinical TrialsStudy DirectorHoffmann-La Roche
2,135 Previous Clinical Trials
901,380 Total Patients Enrolled
27 Trials studying Macular Degeneration
16,180 Patients Enrolled for Macular Degeneration

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
You have previously received at least two anti-VEGF IVT injections for nAMD.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California66.7%
Maryland33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Associated Retina Consultants50.0%
Mid Atlantic Retina - Wills Eye Hospital50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%