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COMPLETED Phase 2

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

NCT04331730 · View on ClinicalTrials.gov ↗

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

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04331730

The ClinicalTrials.gov registry entry for NCT04331730 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkahest, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04331730 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04331730?

The interventions under investigation include: Placebo (DRUG), Aflibercept (DRUG), AKST4290 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04331730?

This trial is sponsored by Alkahest, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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