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NCT05152914 · ClinicalTrials.gov registry record · Phase 1

Intravitreal ERT to Prevent Retinal Disease Progression in Children With CLN2

A Phase 1 study of Neuronal Ceroid Lipofuscinosis Type 2, sponsored by David L Rogers, MD.

Active
Registry status
Phase 1
Development phase
5
Enrollment target
1
Study location

NCT05152914: Active Phase 1 study of Neuronal Ceroid Lipofuscinosis Type 2, sponsored by David L Rogers, MD.

NCT05152914 is a Phase 1 study of Neuronal Ceroid Lipofuscinosis Type 2 that is active but no longer recruiting, run by David L Rogers, MD. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05152914, a Phase 1 study of Neuronal Ceroid Lipofuscinosis Type 2, is active but no longer recruiting, sponsored by David L Rogers, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

This is a phase I/II randomized, masked, clinical trial to determine the safety and efficacy of intravitreal administration of cerliponase alfa.

Primary Outcome

Based on the development of unacceptable toxicity, defined as the occurrence of any Grade 3 or higher, unanticipated, treatment related toxicity.

Interventions

  • DRUG Cerliponase Alfa

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2021-11-01
Est. Completion 2027-11-01
Phase Phase 1
David L Rogers, MD

1 total trials

What the registry record for NCT05152914 still lists

NCT05152914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Neuronal Ceroid Lipofuscinosis Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Cerliponase Alfa is the first listed.

NCT05152914 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT05152914 about?

NCT05152914 is a clinical study titled "Intravitreal ERT to Prevent Retinal Disease Progression in Children With CLN2". This is a phase I/II randomized, masked, clinical trial to determine the safety and efficacy of intravitreal administration of cerliponase alfa.

What is the current status of trial NCT05152914?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2021-11-01. Estimated completion is 2027-11-01.

What conditions does trial NCT05152914 study?

This clinical trial studies the following conditions: Neuronal Ceroid Lipofuscinosis Type 2.

What interventions are being tested in trial NCT05152914?

The interventions under investigation include: Cerliponase Alfa (DRUG).

Who is sponsoring clinical trial NCT05152914?

This trial is sponsored by David L Rogers, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05152914 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05152914's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT05152914, the US trial registry maintained by the National Library of Medicine. NCT05152914 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.