Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study

NCT02902744 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB00082826
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME). Secondary Objectives:
• To collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (4)

• Percentage of patients that require a surgical procedure for increased IOP that could not be controlled by IOP-lowering drops.

  Percentage of patients that require a surgical procedure for increased intraocular pressure that could not be controlled by IOP-lowering drops.

  5 years

• Percentage of patients requiring 1, 2, or 3 medications to control IOP.

  Percentage of patients requiring 1, 2, or 3 medications to control intraocular pressure.

  5 years

• Percentage of patients with IOP > 25mmHg on two occasions and percentage of patients with IOP > 30mmHg on two occasions

  Percentage of patients with intraocular pressure \> 25mmHg on two occasions and percentage of patients with intraocular pressure \> 30mmHg on two occasions

  5 years

• Percentage of patients losing > 15 letters at month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

  Percentage of patients losing \> 15 letters at month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

  5 years

Secondary Outcomes (6)

• Mean change from baseline BCVA ETDRS letter score at months 12, 24, 36, 48, and 60

  5 years

• Mean change from baseline CST measured by spectral domain-optical coherence tomography (SD-OCT) at months 12, 24, 36, 48, and 60

  5 years

• Percentage of subjects with gain from baseline BCVA letter score ≥ 15; ≥ 10; ≥ 5 at months 12, 24, 36, 48, and 60

  5 years

• Percentage of subjects with CST ≤300µm at months 12, 24, 36, 48, and 60

  5 years

• Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60

  5 years

Study Arms (1)

ILUVIEN 0.19 MG

EXPERIMENTAL

Drug: ILUVIEN®

Interventions

ILUVIEN® DRUG

Patients will receive Iluvien as the standard of care treatment for diabetic macular edema.

Also known as: Fluocinolone Acetonide Intravitreal Implant 0.19 mg

ILUVIEN 0.19 MG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects receiving Iluvien as standard of care for DME
• Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gulnar Hafiz, MD, MPH

  Wilmer Eye Institute, Johns Hopkins Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 16, 2016
• Study Start: March 1, 2017
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)