Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01304706 · ClinicalTrials.gov registry record · Phase 3

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

A Phase 3 study, sponsored by Alimera Sciences.

Completed
Registry status
Phase 3
Development phase
120
Enrollment target

NCT01304706: Completed Phase 3 study, sponsored by Alimera Sciences.

NCT01304706 is a Phase 3 study that has completed, run by Alimera Sciences. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01304706, a Phase 3 study, has completed, sponsored by Alimera Sciences.

COMPLETED
Registry status
Phase 3
Development phase
120 participants
Enrollment target

Study Summary

This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

Primary Outcome

This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.

Interventions

  • DRUG Fluocinolone Acetonide

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2011-04
Phase Phase 3
Alimera Sciences

8 total trials

What the finished NCT01304706 record still lists

NCT01304706 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which Fluocinolone Acetonide is the first listed.

NCT01304706 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01304706 about?

NCT01304706 is a clinical study titled "Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study". This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

What is the current status of trial NCT01304706?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2011-04.

What interventions are being tested in trial NCT01304706?

The interventions under investigation include: Fluocinolone Acetonide (DRUG).

Who is sponsoring clinical trial NCT01304706?

This trial is sponsored by Alimera Sciences, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01304706's enrollment target sits among peer trials

120 1619th of 2000 higher than 361 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01174108 · 120 participants · Phase 2

    Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells

  • NCT01627301 · 120 participants · NA

    Sympathetic Overactivity in Post-traumatic Stress Disorder

  • NCT02025023 · 120 participants · Phase 3

    Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

  • NCT02128906 · 120 participants · Phase 2

    Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01304706, the US trial registry maintained by the National Library of Medicine. NCT01304706 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.