Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study
NCT02902744 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2017-08-22
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
Interventions
- DRUG
-
ILUVIEN®
Patients will receive Iluvien as the standard of care treatment for diabetic macular edema.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Gulnar Hafiz, MD, MPH · Wilmer Eye Institute, Johns Hopkins Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-01
- Primary Completion
- 2017-08-18
- Completion
- 2017-08-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide Implant
NCT04340505 ·Status: COMPLETED
-
Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.
NCT06539481 ·Status: RECRUITING ·Phase: PHASE4
-
A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema
NCT01994291 ·Status: TERMINATED ·Phase: PHASE2
-
A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion
NCT01277302 ·Status: COMPLETED ·Phase: PHASE4
-
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
NCT06662994 ·Status: RECRUITING ·Phase: PHASE4
-
A Study of the Safety and Tolerability of Intravitreal LKA651 in Patients With Diabetic Macular Edema
NCT02281292 ·Status: WITHDRAWN ·Phase: PHASE1
-
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase
NCT02032173 ·Status: TERMINATED ·Phase: PHASE3
-
Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema
NCT02842541 ·Status: WITHDRAWN ·Phase: PHASE1
-
The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates
NCT02448446 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
NCT00468871 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing
NCT02127684 ·Status: WITHDRAWN ·Phase: PHASE2
-
Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab
NCT03059277 ·Status: WITHDRAWN ·Phase: PHASE4
-
A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
NCT06305416 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
NCT00387582 ·Status: COMPLETED ·Phase: PHASE2
-
Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration
NCT00423189 ·Status: TERMINATED ·Phase: PHASE4
-
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
NCT01476449 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
NCT01627249 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Ranibizumab for Diabetic Macular Edema
NCT01982435 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations
NCT00831350 ·Status: COMPLETED ·Phase: PHASE2
-
Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
NCT01472510 ·Status: COMPLETED ·Phase: PHASE2
-
Variable Interval Versus Set Interval Aflibercept for DME
NCT02392364 ·Status: COMPLETED ·Phase: PHASE4
-
Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study
NCT01813773 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)
NCT01565148 ·Status: TERMINATED ·Phase: PHASE2
-
Observation of Treatment Patterns With Lucentis in Approved Indications
NCT02194803 ·Status: COMPLETED
-
Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate
NCT01314417 ·Status: TERMINATED ·Phase: PHASE1/PHASE2