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A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04615325
Collaborator
(none)
63
Enrollment
13
Locations
4
Arms
24.8
Anticipated Duration (Months)
4.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single Intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age related macular degeneration (AMD). The participants will receive ITV injections of RO7303359 in the single ascending dose stage and maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 will be administered in the expansion stage.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1a, Multicenter, Open Label, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age Related Macular Degeneration
Actual Study Start Date :
Dec 8, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single ascending dose stage

Patients will receive a single dose of RO7303359, in multiple escalating cohorts (A-D)

Drug: RO7303359
RO730359 will be administered at a single intravitreal injection
Experimental: Expansion cohort stage

Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.

Drug: RO7303359
RO730359 will be administered at a single intravitreal injection
Experimental: Optional cohort E

An optional additional cohort maybe added with the dose not exceed the MTD or MTeD

Drug: RO7303359
RO730359 will be administered at a single intravitreal injection
Experimental: Optional cohort F

An optional additional cohort maybe added with the dose not exceed the MTD or MTeD

Drug: RO7303359
RO730359 will be administered at a single intravitreal injection

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants with Adverse Events and Serious Adverse Events [Up to 12 Weeks]

    Adverse events will be determined by the World Health Organization toxicity grading scale

  2. Proportion of participants with changes in best corrected visual acuity (BCVA) following RO7303359 administration [Up to 12 Weeks]

Secondary Outcome Measures

  1. Serum concentration of RO7303359 [Up to 12 Weeks]

  2. Aqueous humor concentration of RO7303359 [Up to 12 Weeks]

  3. Concentration of serum anti drug antibodies (ADAs) at baseline and incidence of serum ADAs [Up to 12 Weeks]

  4. Proportion of participants with anti-drug-antibodies (ADA) to RO7303359 [Up to 12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Ocular Inclusion Criteria Study Eye:

  • Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)

  • GA area must be >= 0.5 disc area (1.25 mm2)

Ocular Exclusion Criteria, Study eye:

  • GA due to causes other than AMD

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD

  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy

  • Prior treatment with Visudyne, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria, Both eyes:

  • Evidence of prior or active CNV

  • Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e. ocular or systemic) within the last 6 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Retina Partners Encino California United States 91436
2 Northern California Retina Vitreous Associates Mountain View California United States 94040
3 Retinal Consultants Med Group Sacramento California United States 95825
4 California Retina Consultants - Santa Maria Santa Maria California United States 93454
5 Colorado Retina Associates, PC Denver Colorado United States 80230
6 Florida Eye Associates Melbourne Florida United States 32901
7 University Retina and Macula Associates, PC Lemont Illinois United States 60439
8 Associated Retinal Consultants PC Royal Oak Michigan United States 48073
9 Sierra Eye Associates Reno Nevada United States 89502
10 Western Carolina Retinal Associate PA Asheville North Carolina United States 28803
11 Tennessee Retina PC. Nashville Tennessee United States 37203
12 Austin Clinical Research LLC Austin Texas United States 78750
13 Retina Foundation of the Southwest Dallas Texas United States 75231

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04615325
Other Study ID Numbers:
  • GR42163
First Posted:
Nov 4, 2020
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Aug 25, 2022