Status:
ACTIVE_NOT_RECRUITING
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Lead Sponsor:
Alimera Sciences
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, masked, active-controlled, parallel-group, multi-center study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME (CI-DME). Th...
Eligibility Criteria
Inclusion
- Major
- Male or female subjects ≥18 years of age at the time of consent.
- Must have CI-DME confirmed by Spectral Domain Ocular Coherence Tomography (SD-OCT) and Center Subfield Thickness (CST) of: ≥350 µm in the study eye.
- Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.
- Major
Exclusion
- Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
- History or current diagnosis of glaucoma or ocular hypertension (OHT) or a cup to disc ratio \>0.8; History of uncontrolled intraocular pressure (defined as IOP ≥25 mmHg with maximum topical and systemic medical hypotensive treatment) or previous filtration surgery in the study eye at Screening Visit.
- Other conditions that can cause macular edema.
- Patients who received prior LASER photocoagulation therapy including macular grid or pan retina photocoagulation (PRP) at any time in the study eye. Prior focal LASER photocoagulation therapy outside the macula is allowed.
- Patients who received the following therapies in the study eye:
- Intravitreal or periocular steroids;
- Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
- Patients who received \>1 intravitreal injection of ranibizumab or bevacizumab in the last 12 months; or have received ranibizumab or bevacizumab ≤6 weeks prior to Screening Visit
- Patients who have lens opacities due to cataract or other etiologies that would make it difficult to examine the fundus or that affect the patients Activities of Daily Living (ADL).
- Steroid Challenge Exclusion Criterion- At the Baseline Visit, patients who are determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from Screening will be excluded from the study.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04469595
Start Date
August 31 2020
End Date
December 31 2024
Last Update
July 31 2024
Active Locations (40)
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1
Investigative Site
Phoenix, Arizona, United States, 85020
2
Investigative Site
Tucson, Arizona, United States, 85704
3
Investigative Site
Beverly Hills, California, United States, 90211
4
Investigative Site
Glendale, California, United States, 91203