Diabetic Macular Edema Clinical Trial
— FADOfficial title:
Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study
Verified date | August 2017 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 18, 2017 |
Est. primary completion date | August 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: • None |
Country | Name | City | State |
---|---|---|---|
United States | Wilmer Eye Institute, Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Mean change from baseline BCVA ETDRS letter score at months 12, 24, 36, 48, and 60 | Mean change from baseline best corrected visual acuity (BCVA) ETDRS letter score at months 12, 24, 36, 48, and 60 | 5 years | |
Secondary | Mean change from baseline CST measured by spectral domain-optical coherence tomography (SD-OCT) at months 12, 24, 36, 48, and 60 | Mean change from baseline central subfield thickness (CST) measured by spectral domain-optical coherence tomography (SD-OCT) at months 12, 24, 36, 48, and 60 | 5 years | |
Secondary | Percentage of subjects with gain from baseline BCVA letter score = 15; = 10; = 5 at months 12, 24, 36, 48, and 60 | Percentage of subjects with gain from baseline best corrected visual acuity (BCVA) letter score = 15; = 10; = 5 at months 12, 24, 36, 48, and 60 | 5 years | |
Secondary | Percentage of subjects with CST =300µm at months 12, 24, 36, 48, and 60 | Percentage of subjects with central subfield thickness (CST) =300µm at months 12, 24, 36, 48, and 60 | 5 years | |
Secondary | Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60 | Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60 | 5 years | |
Secondary | Number of anti-VEGF injections required between baseline and month 60 | Number of anti-VEGF injections required between baseline and month 60 | 5 years |
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