A Study of NGM621 in Participants With Geographic Atrophy (CATALINA)

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy

Treatments: Other: Sham Comparator; Biological: NGM621

Study type: Interventional

Funder types: Industry

Identifiers

NCT04465955

621-GA-201

Details and patient eligibility

About

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

Enrollment: 320 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (non-pregnant, non-lactating) subjects ≥ 55 years

• Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye

• Clinical diagnosis of GA secondary to AMD:

  1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
  2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
  3. Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye

Exclusion criteria

Study Eye

• GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
• Any history of or active choroidal neovascularization (CNV)

Both Eyes

• Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 4 patient groups

NGM621 Treatment Group A (every 4 weeks)

Experimental group

Description:

NGM621 single intravitreal (IVT) injection

Treatment:

Biological: NGM621

Biological: NGM621

NGM621 Treatment Group C (every 8 weeks)

Experimental group

Description:

NGM621 single IVT injection

Treatment:

Biological: NGM621

Biological: NGM621

Sham Group B (every 4 weeks)

Sham Comparator group

Description:

Sham single IVT injection

Treatment:

Other: Sham Comparator

Sham Group D (every 8 weeks)

Sham Comparator group

Description:

Sham single IVT injection

Treatment:

Other: Sham Comparator