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Mitochondrial Peptide

Elamipretide for Age-Related Macular Degeneration (ReNEW Trial)

Phase 3

Recruiting

Research Sponsored by Stealth BioTherapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Extrafoveal GA defined as well-demarcated area(s) of GA where all GA lesions must be at least 150 μm from foveal center

Adults ≥ 55 years of age with at least 1 eye with dry AMD with photoreceptor loss, as determined at the Screening Visit by the presence of extrafoveal geographic atrophy (GA)

Must not have

Atrophic retinal disease of causality other than AMD in the study eye

eGFR of < 30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 96

Awards & highlights

Summary

This trial aims to see if a drug called elamipretide is effective, safe, and well-tolerated for people with dry age-related macular degeneration (AMD). They want to

Who is the study for?

This trial is for people with dry age-related macular degeneration (AMD). Participants should have a specific level of vision loss and clear enough eyes for imaging. They must be able to take daily injections or have someone who can administer them. Those with certain other eye conditions or treatments are excluded.

What is being tested?

The study tests the effectiveness and safety of elamipretide, administered through daily shots, against a placebo in slowing down photoreceptor loss in the retina due to dry AMD. The comparison will help determine if elamipretide can benefit patients with this condition.

What are the potential side effects?

While specific side effects aren't listed here, common ones from subcutaneous injections may include pain at the injection site, swelling, redness, bruising, itching and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eye condition is away from the central vision area.

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I am 55 or older with dry AMD and loss of vision not in the center of my eye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My vision loss is not due to AMD.

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My kidney function is severely reduced.

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I have advanced glaucoma or significant eye issues in the study eye.

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I have an eye condition like diabetic retinopathy or an eye infection.

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I am not taking any medication that could harm my eyes.

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I have a specific eye condition affecting my vision.

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My eye condition involves fluid leakage or abnormal blood vessels.

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I have severe eye conditions affecting my vision.

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I have had recent eye surgery or treatment in the affected eye.

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I have an eye condition that might need treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 96 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Week 48 Rate of change in the macular area of photoreceptor loss

Secondary outcome measures

Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA)

Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA)

Week 72 Rate of change in the Macular area of photoreceptor loss

+1 more

Side effects data

From 2021 Phase 2 & 3 trial • 12 Patients • NCT03098797

100%

Dizziness

60%

Injection site pruritus

60%

Injection site erythema

60%

Injection site pain

40%

Headache

40%

Injection site urticaria

40%

Injection site induration

40%

Nausea

40%

Drug eruption

20%

Gastroenteritis

20%

Viral upper respiratory tract infection

20%

Pain in extremity

20%

Aphthous ulcer

20%

Eczema

20%

Leukopenia

20%

Palpitations

20%

Feeling cold

20%

Vessel puncture site bruise

20%

Injection site cellulitis

20%

Procedural vomiting

20%

Echocardiogram abnormal

20%

Myalgia

20%

Anxiety

20%

Initial insomnia

20%

Urticaria

20%

Vaccination site rash

20%

Eosinophil count increased

100%

80%

60%

40%

20%

Study treatment Arm

Part 2 (OLE): Elamipretide (Sequence AB)

Part 2 (OLE): Elamipretide (Sequence BA)

Part 1: Elamipretide

Part 1: Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ElamipretideExperimental Treatment1 Intervention

Subjects will receive once daily subcutaneous doses of 40mg elamipretide for 96 weeks

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive once daily subcutaneous doses of placebo for 96 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elamipretide

2016

Completed Phase 3

~150

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stealth BioTherapeutics Inc.Lead Sponsor

28 Previous Clinical Trials

1,890 Total Patients Enrolled

Rekha SathyanarayanaStudy DirectorStealth BioTherapeutics

4 Previous Clinical Trials

982 Total Patients Enrolled

~240 spots leftby Aug 2026

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