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A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Primary Purpose

Geographic Atrophy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RO7303359
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northern California Retina Vitreous Associates
  • Retinal Consultants Med Group
  • California Retina Consultants - Santa Maria
  • Colorado Retina Associates, PC
  • Florida Eye Associates
  • University Retina and Macula Associates, PC
  • Associated Retinal Consultants PC
  • Sierra Eye Associates
  • Western Carolina Retinal Associate PA
  • Tennessee Retina PC.
  • Austin Clinical Research LLC
  • Retina Foundation of the Southwest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Single Ascending Dose Stage

Expansion Cohort Stage

Optional Cohort E

Optional cohort F

Arm Description

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

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

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Outcomes

Primary Outcome Measures

Percentage of Participants With Ocular Adverse Events
Percentage of Participants With Systemic Adverse Events
Percentage of Participants With Dose-limiting Adverse Events (DLAEs),
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of Participants With Adverse Events Leading to Study Discontinuation
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart

Secondary Outcome Measures

Full Information

First Posted
October 29, 2020
Last Updated
February 27, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04615325
Brief Title
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Ascending Dose Stage
Arm Type
Experimental
Arm Description
Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).
Arm Title
Expansion Cohort Stage
Arm Type
Experimental
Arm Description
Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.
Arm Title
Optional Cohort E
Arm Type
Experimental
Arm Description
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
Arm Title
Optional cohort F
Arm Type
Experimental
Arm Description
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
Intervention Type
Drug
Intervention Name(s)
RO7303359
Intervention Description
RO730359 will be administered as a single intravitreal injection.
Primary Outcome Measure Information:
Title
Percentage of Participants With Ocular Adverse Events
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Systemic Adverse Events
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Dose-limiting Adverse Events (DLAEs),
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Adverse Events Leading to Study Discontinuation
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time Frame
Up to 12 weeks
Title
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ocular Inclusion Criteria Study Eye: Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters 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 mm^2) Ocular Exclusion Criteria, Study Eye: GA in the study eye 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 photodynamic therapy, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Retina Consultants - Santa Maria
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Associated Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Tennessee Retina PC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Austin Clinical Research LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

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