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NCT04331730 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD

A Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Alkahest.

Completed
Registry status
Phase 2
Development phase
107
Enrollment target
20
Study locations

NCT04331730 is a Phase 2 study of Neovascular Age-related Macular Degeneration that has completed, run by Alkahest. The registered enrollment target is 107 participants, below the 405-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT04331730, a Phase 2 study of Neovascular Age-related Macular Degeneration, has completed, sponsored by Alkahest.

COMPLETED
Registry status
Phase 2
Development phase
107 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy and safety of AKST4290 in combination with aflibercept injections in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD).

Interventions

  • DRUG Placebo
  • DRUG Aflibercept
  • DRUG AKST4290

Study Locations (20)

Other

  • Internationale Innovative Ophthalmochirurgie GbR - Düsseldorf
  • nordBLICK Augenklinik Bellevue - Kiel
  • Augentagesklinik Rheine - Rheine
  • Jahn Ferenc Dél-pesti Kórház (Jahn Ferenc South-Pest Hospital) - Budapest
  • Magyar Honvédség Egészségügyi Központ, Szemészeti Osztály (Medical Centre, Hungarian Defence Forces, Ophthalmology Department) - Budapest
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház (Borsod-Abaúj-Zemplén County Hospital and University Teaching Hospital) - Miskolc
  • GANGLION Orvosi Központ - Pécs
  • Szegedi Tudományegyetem Általános Orvostudományi Kar, Szent-Györgyi Albert Klinikai Központ, Szemészeti Klinika, (University of Szeged Faculty of Medicine, Albert-Szent Gyorgyi Health Care, Department of Ophthalmology) - Szekszárd
  • Tęczówka (IRIS) - Bialystok
  • Specjalistyczny Ośrodek Okulistyczny Oculomedica (Specialized Eye Center Oculomedica) - Bydgoszcz
  • PROVISUS Sp. z o.o. - Częstochowa
  • Optimum Profesorskie Centrum Okulistyki - Gdansk
  • Centrum Medyczne Dietla 19 Sp zoo - Krakow
  • Klinika Chirurgii Siatkówki i Ciała Szklistego Medical University in Lublin - Lublin
  • Szpital św. Wojciecha - Poznan
  • ArtOptica Salon Okulistyczno - Suwałki
  • Centrum Medyczne UNO-MED - Tarnów

California

  • Retina-Vitreous Associates Medical Group - Beverly Hills

Florida

  • Retina Vitreous Associates of FL - St. Petersburg

Nevada

  • Sierra Eye Associates - Reno

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2020-01-28
Est. Completion 2021-09-16
Phase Phase 2

Sponsor

Alkahest

9 total trials

What the Registry Record Tells You About NCT04331730

The ClinicalTrials.gov registry entry for NCT04331730 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 405-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (74% lower). The listed sponsor is Alkahest, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT04331730 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04331730 about?

NCT04331730 is a clinical study titled "A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD". This study will evaluate the efficacy and safety of AKST4290 in combination with aflibercept injections in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD).

What is the current status of trial NCT04331730?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2020-01-28. Estimated completion is 2021-09-16.

What conditions does trial NCT04331730 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.

What interventions are being tested in trial NCT04331730?

The interventions under investigation include: Placebo (DRUG), Aflibercept (DRUG), AKST4290 (DRUG).

Who is sponsoring clinical trial NCT04331730?

This trial is sponsored by Alkahest, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04331730 being conducted?

This trial has 20 study locations across California, Florida, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.