ReNEW: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects who have Dry Age-Related Macular Degeneration (Dry AMD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511482-11-00

Acronym

SPIAM-301

Enrollment

Registered

2024-09-20

Start date

2024-11-20

Completion date

Unknown

Last updated

2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age-Related Macular Degeneration (Dry AMD)

Brief summary

Rate of change in the macular area of photoreceptor loss (defined as an Ellipsoid Zone – Retinal Pigment Epithelium (EZ-RPE) thickness of 0μm) assessed by spectral domain-optical coherence tomography (SD-OCT) and Ellipsoid Zone (EZ) mapping at Week 48

Detailed description

Efficacy: Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT and EZ mapping at Week 72, Efficacy: Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT and EZ mapping at Week 96, Efficacy: Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA) from baseline at Week 48, Efficacy: Proportion of subjects gaining ≥ 15 letters (3 lines) in LL BCVA from baseline at Week 48

Interventions

DRUGThe placebo for this trial will be composed of excipients used to manufacture the investigational drug but without the active drug substance.

DRUGElamipretide

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of change in the macular area of photoreceptor loss (defined as an Ellipsoid Zone – Retinal Pigment Epithelium (EZ-RPE) thickness of 0μm) assessed by spectral domain-optical coherence tomography (SD-OCT) and Ellipsoid Zone (EZ) mapping at Week 48	—

Secondary

Measure	Time frame
Efficacy: Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT and EZ mapping at Week 72, Efficacy: Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT and EZ mapping at Week 96, Efficacy: Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA) from baseline at Week 48, Efficacy: Proportion of subjects gaining ≥ 15 letters (3 lines) in LL BCVA from baseline at Week 48	—

Measure

Time frame

—

Countries

Czechia, Germany, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026