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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: Completed Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Alkahest.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Mean change from baseline in Best Corrected Visual Acuity (BCVA) per the Early Treatment Diabetic Retinopathy Study (ETDRS) testing method. BCVA will be assessed using ETDRS charts at 4 meters initial testing distance and assessed in both eyes. Score range is 0 to 93. A higher score indicates better vision.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 2 |
What the finished NCT04331730 record still lists
NCT04331730 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 405-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (74% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Neovascular Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04331730's enrollment target sits among peer trials
107 15th of 33 higher than 19 of 33 other Neovascular Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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