Skip to main content
OpenTrials
Completed

NCT Number: NCT04615325

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northern California Retina Vitreous Associates, Mountain View, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7303359

Drug

RO730359 will be administered as a single intravitreal injection.

Primary outcomes

  1. Percentage of Participants With Ocular Adverse Events

    Time frame: Up to 12 weeks

  2. Percentage of Participants With Systemic Adverse Events

    Time frame: Up to 12 weeks

  3. Percentage of Participants With Dose-limiting Adverse Events (DLAEs),

    Time frame: Up to 12 weeks

  4. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 12 weeks

  5. Percentage of Participants With Adverse Events Leading to Study Discontinuation

    Time frame: Up to 12 weeks

  6. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Up to 12 weeks

  7. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.