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NCT04008121 · ClinicalTrials.gov registry record · Early Phase 1
Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
A Early Phase 1 study of Diabetic Retinopathy and Macular Degeneration, sponsored by MediBeacon.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04008121: Recruiting Early Phase 1 study of Diabetic Retinopathy and Macular Degeneration, sponsored by MediBeacon.
NCT04008121 is a Early Phase 1 study of Diabetic Retinopathy and Macular Degeneration that is actively recruiting participants, run by MediBeacon. The registered enrollment target is 10 participants, below the 1,676-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04008121, a Early Phase 1 study of Diabetic Retinopathy and Macular Degeneration, is actively recruiting participants, sponsored by MediBeacon.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.
Primary Outcome
Ocular angiography will be performed using a commercially available, FDA-approved clinical Zeiss FF450 fundus camera. Images will be taken of both eyes, acquired by a trained ophthalmic photographer. In at least 2 participants, imaging will also be conducted using 2 different additional clinically-approved ocular angiography imaging systems.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Fluorescein sodium and Zeiss FF450 fundus camera
- COMBINATION_PRODUCT MB-102 and Zeiss FF450 fundus camera
- COMBINATION_PRODUCT Fluorescein sodium and commercially available optical angiography imaging system
- COMBINATION_PRODUCT MB-102 and commercially available optical angiography imaging system
Study Locations (1)
Michigan
- University of Michigan Kellogg Eye Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-11-06 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What NCT04008121 shows while recruiting
NCT04008121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,676-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Diabetic Retinopathy appearing as the primary indexed condition, and to 4 interventions - of which Fluorescein sodium and Zeiss FF450 fundus camera is the first listed.
NCT04008121 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04008121 about?
NCT04008121 is a clinical study titled "Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium". The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.
What is the current status of trial NCT04008121?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2025-11-06. Estimated completion is 2026-12.
What conditions does trial NCT04008121 study?
This clinical trial studies the following conditions: Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion, Retinopathy.
What interventions are being tested in trial NCT04008121?
The interventions under investigation include: Fluorescein sodium and Zeiss FF450 fundus camera (COMBINATION_PRODUCT), MB-102 and Zeiss FF450 fundus camera (COMBINATION_PRODUCT), Fluorescein sodium and commercially available optical angiography imaging system (COMBINATION_PRODUCT), MB-102 and commercially available optical angiography imaging system (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04008121?
This trial is sponsored by MediBeacon, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04008121 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04008121's enrollment target sits among peer trials
10 56th of 57 higher than 1 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy 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.
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