Clinical trial NCT04469595: A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Official title: A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: DME
CI-DME
Diabetic Macular Edema
Diabetic Retinopathy
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, masked, active-controlled, multi-center study
Primary purpose: TREATMENT

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). The study will enroll patients who are either treatment naïve 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).


Eligibility criteria: Major Inclusion Criteria:

1. Male or female subjects ≥18 years of age at the time of consent.
2. 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.
3. Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.

Major Exclusion Criteria:

1. Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
2. 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.
3. Other conditions that can cause macular edema.
4. 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.
5. Patients who received the following therapies in the study eye:

   1. Intravitreal or periocular steroids;
   2. Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
6. 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
7. 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).
8. 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.

Primary outcomes:
measure: The mean total number of supplemental aflibercept injections needed during the study
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline
timeFrame: At 18 months
measure: Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline to 18 months
measure: Mean change from baseline in Center Subfield Thickness (CST)
timeFrame: Baseline to 18 months
measure: Area under the curve (AUC) of Center Subfield Thickness (CST)
timeFrame: Baseline to 18 months
measure: Mean change from baseline in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and subscale scores
timeFrame: At 18 months
measure: Safety Outcome Endpoints: The incidence and severity of treatment-related adverse events
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Investigative Site
state: Arizona
city: Beverly Hills
country: United States
facility: Investigative Site
state: California
city: Glendale
country: United States
facility: Investigative Site
state: California
city: Laguna Hills
country: United States
facility: Investigative Site
state: California
city: Santa Ana
country: United States
facility: Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Investigative Site
state: Colorado
city: Clearwater
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: Marietta
country: United States
facility: Investigative Site
state: Georgia
city: Sandy Springs
country: United States
facility: Investigative Site
state: Georgia
city: Elmhurst
country: United States
facility: Investigative Site
state: Illinois
city: Lemont
country: United States
facility: Investigative Site
state: Illinois
city: Oak Park
country: United States
facility: Investigative Site
state: Illinois
city: Springfield
country: United States
facility: Investigative Site
state: Illinois
city: Leawood
country: United States
facility: Investigative Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Investigative Site
state: Kansas
city: West Monroe
country: United States
facility: Investigative Site
state: Louisiana
city: Baltimore
country: United States
facility: Investigative Site
state: Maryland
city: Detroit
country: United States
facility: Investigative Site
state: Michigan
city: Grand Blanc
country: United States
facility: Investigative Site
state: Michigan
city: Independence
country: United States
facility: Investigative Site
state: Missouri
city: Bloomfield
country: United States
facility: Investigative Site
state: New Jersey
city: Beachwood
country: United States
facility: Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Investigative Site
state: Ohio
city: Youngstown
country: United States
facility: Investigative Site
state: Ohio
city: Tulsa
country: United States
facility: Investigative Site
state: Oklahoma
city: Erie
country: United States
facility: Investigative Site
state: Pennsylvania
city: Columbia
country: United States
facility: Investigative Site
state: South Carolina
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: McAllen
country: United States
facility: Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: The Woodlands
country: United States
facility: Investigative Site
state: Texas
city: Roanoke
country: United States
facility: Investigative Site
state: Virginia
city: Warrenton
country: United States
facility: Investigative Site
state: Virginia
Study officials:
References: