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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
Pivotal Trial

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Week 48 Rate of change in the macular area of photoreceptor loss
Secondary study objectives
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%
0%
Study treatment Arm
Part 2 (OLE): Elamipretide (Sequence AB)
Part 2 (OLE): Elamipretide (Sequence BA)
Part 1: Elamipretide
Part 1: Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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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