Today, we will be looking into the latest research and clinical trials focused on age-related macular degeneration in adults.

The following list has been carefully curated by evaluating the ongoing Phase 3 trials that are currently recruiting for age-related macular degeneration, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Without further ado, let us explore the list of Age-Related Macular Degeneration Clinical Trials!

Quick View Table of Age-Related Macular Degeneration Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)PHASE 3660 12/28/202110/16/2024
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMDPHASE 360011/9/202312/5/2024
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular DegenerationPHASE 33001/29/20247/5/2024
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) (ReNEW)PHASE 33605/30/20241/22/2025
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) (ELARA)PHASE 310007/24/20241/13/2025
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular DegenerationPHASE 382511/27/20241/15/2025
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK (DAYBREAK)PHASE 36758/23/20241/7/2025
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 52 (wAMD)PHASE 340010/22/202411/1/2024
A 2-year Study of EYP-1901 in Subjects with Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will Be Determined At Week 52 (wAMD)PHASE 3400 11/27/202412/13/2024

Phase 3 Clinical Trials:

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)

Study Details | Source

  • Sponsor: AbbVie
  • ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
  • Interventions:
    • Genetic: ABBV-RGX-314 Dose 1
    • Genetic: ABBV-RGX-314 Dose 2
    • Biological: Aflibercept (EYLEA®)
  • Primary Outcomes Measures:
    • Mean change from baseline in Best Corrected Visual Acuity (BCVA)
      • BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS), at Week 54

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

Study Details | Source

  • Sponsor: Jaeb Center for Health Research
  • Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
  • Interventions:
    • Drug: Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
    • Device: Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
  • Primary Outcomes Measures:
    • E-ETDRS Change in Visual Acuity Letter Score
      • Best-corrected visual acuity following protocol-defined refraction. Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity. Baseline to 104 weeks
    • Number of intravitreal injections of Faricimab (6.0 mg) in the study eye. Baseline to 104 weeks

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

Study Details | Source

  • Sponsor: Ocular Therapeutix, Inc.
  • Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration.
  • Interventions:
    • Drug: OTX-TKI (axitinib implant)
    • Drug: Aflibercept
  • Primary Outcomes Measures:
    • Best corrected visual acuity (BCVA)
      • Maintenance of visual acuity, defined as < 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss, Up to 36 Weeks

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) (ReNEW)

Study Details | Source

  • Sponsor: Stealth BioTherapeutics Inc.
  • The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared.
  • Interventions:
    • Drug: Elamipretide
    • Drug: Placebo
  • Primary Outcomes Measures:
    • Week 48 Rate of change in the macular area of photoreceptor loss
      • 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 48. Baseline, Week 48

A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) (ELARA)

Study Details | Source

  • Sponsor: Regeneron Pharmaceuticals
  • This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.
  • The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.
  • Interventions:
    • Drug: Aflibercept 8 mg
  • Primary Outcomes Measures:
    • Occurrence of treatment-emergent adverse events (TEAEs)
      • Through week 24
    • Occurrence of serious TEAEs
      • Through week 24

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

Study Details | Source

  • Sponsor: Ocular Therapeutix, Inc.
  • Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration.
  • Interventions:
    • Drug: OTX-TKI
    • Drug: Aflibercept
    • Drug: Aflibercept
  • Primary Outcomes Measures:
    • Best Corrected Visual Acuity (BCVA)
      • Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK (DAYBREAK)

Study Details | Source

  • Sponsor: Kodiak Sciences Inc
  • A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD).
  • Interventions:
    • Drug: Tarcocimab tedromer
    • Drug: Tabirafusp tedromer
    • Drug: Aflibercept
  • Primary Outcomes Measures:
    • Best corrected visual acuity (PCVA)
      • Mean change in BCVA from Day 1 to Year 1 at Week 48

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 52 (wAMD)

Study Details | Source

  • Sponsor: EyePoint Pharmaceuticals, Inc.
  • This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
  • Interventions:
    • Drug: EYP-1901
    • Drug: Aflibercept (2.0 mg)
  • Primary Outcomes Measures:
    • Average change in best corrected visual acuity (BCVA)
      • Weeks 52 and 56

A 2-year Study of EYP-1901 in Subjects with Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will Be Determined At Week 52 (wAMD)

Study Details | Source

  • Sponsor: EyePoint Pharmaceuticals, Inc.
  • This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
  • Interventions:
    • Drug: EYP-1901
    • Drug: Aflibercept (2.0 mg)
  • Primary Outcomes Measures:
    • Average change in best corrected visual acuity (BCVA)
      • Weeks 52 and 56

Potential Guideline That May Be Affected Includes:

There you have it - a list of phase 3 clinical trials for age-related macular degeneration as of January 2025. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.

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