A Study of Intravitreal ILUVIEN Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

STATUS

Recruiting
participants needed

300
sponsor

Alimera Sciences

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Updated on 19 February 2024

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macular edema

corrected visual acuity

aflibercept

spectral domain optical coherence tomography

edema

diabetic macular edema

sd-oct

iluvien

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). The study will enroll patients who are either treatment nave or have not received any DME treatments for the preceding 12 months as documented in medical records. Patients who received DME treatment >12 months before screening, must not have received >4 intravitreal injections. The study will compare 2 treatment regimens: ILUVIEN intravitreal implant (0.19 mg) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL), compared to intravitreal aflibercept loading dose (2 mg administered by intravitreal injection every 4 weeks for 5 consecutive doses) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL).

Details

Condition	Diabetic Macular Edema
Age	18-100 years
Treatment	Aflibercept, Iluvien 0.19 MG Drug Implant
Clinical Study Identifier	NCT04469595
Sponsor	Alimera Sciences
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 m in the study eye
	Best Corrected Visual Acuity (BCVA) of 80 ETDRS Letters and 35 ETDRS letters in the study eye at Screening Visit
Exclusion Criteria
	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 last 12 months prior to
	screening
	Intravitreal or periocular steroids in the study eye
	Any intravitreal anti-VEGF [vascular endothelial growth factor (VEGF)] (including but not limited to bevacizumab, ranibizumab, or aflibercept)
	Patients who received intravitreal anti-VEGF or corticosteroids >12 months prior to the Screening Visit will be allowed in the study, provided that they have not received a total of >4 injections
	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

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A Study of Intravitreal ILUVIEN Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)