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Monoclonal Antibodies

NGM621 for Age-Related Macular Degeneration (CATALINA Trial)

Phase 2

Waitlist Available

Research Sponsored by NGM Biopharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

CATALINA Trial Summary

This trial is testing a new drug for age-related macular degeneration.

Eligible Conditions

Age-Related Macular Degeneration (AMD)

CATALINA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham

The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment

CATALINA Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: NGM621 Treatment Group C (every 8 weeks)Experimental Treatment1 Intervention

NGM621 single IVT injection

Group II: NGM621 Treatment Group A (every 4 weeks)Experimental Treatment1 Intervention

NGM621 single intravitreal (IVT) injection

Group III: Sham Group B (every 4 weeks)Placebo Group1 Intervention

Sham single IVT injection

Group IV: Sham Group D (every 8 weeks)Placebo Group1 Intervention

Sham single IVT injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NGM621

2019

Completed Phase 2

~340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor

23 Previous Clinical Trials

1,901 Total Patients Enrolled

NGM Study DirectorStudy DirectorNGM Biopharmaceuticals

9 Previous Clinical Trials

833 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential safety concerns should be taken into account when utilizing NGM621?

"NGM621's safety rating is a 2 on the scale of 1 to 3 due to its Phase 2 status, indicating that while there are indications of its safety profile, no data has been collected surrounding efficacy."

Answered by AI

How many health facilities are hosting this experimental protocol?

"This trial is being hosted in many different locations, including Associated Retina Consultants PC in Traverse City and Southeast Clinical Research in Charlotte. Additionally, Western Carolina Retinal Associates in Asheville also participates alongside 65 other sites."

Answered by AI

Is this examination open to participants at the present moment?

"The clinicaltrial.gov platform indicates that this medical trial is not currently accepting participants, as the posting was last edited on August 19th 2021. While no longer recruiting patients for this particular study, there are 189 other trials actively seeking volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NGM621 in Participants With Geographic Atrophy

2020. "A Study of NGM621 in Participants With Geographic Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04465955.