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

Diabetic Macular Edema Clinical Trial

— NEW DAY  

Official title:

A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04469595
• Other study ID #: 01-20-005
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 31, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
• Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection

Locations

Country	Name	City	State
United States	Investigative Site	Baltimore	Maryland
United States	Investigative Site	Beachwood	Ohio
United States	Investigative Site	Beverly Hills	California
United States	Investigative Site	Bloomfield	New Jersey
United States	Investigative Site	Cincinnati	Ohio
United States	Investigative Site	Clearwater	Florida
United States	Investigative Site	Cleveland	Ohio
United States	Investigative Site	Colorado Springs	Colorado
United States	Investigative Site	Columbia	South Carolina
United States	Investigative Site	Dallas	Texas
United States	Investigative Site	Detroit	Michigan
United States	Investigative Site	Elmhurst	Illinois
United States	Investigative Site	Erie	Pennsylvania
United States	Investigative Site	Glendale	California
United States	Investigative Site	Grand Blanc	Michigan
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Independence	Missouri
United States	Investigative Site	Laguna Hills	California
United States	Investigative Site	Leawood	Kansas
United States	Investigative Site	Lemont	Illinois
United States	Investigative Site	Marietta	Georgia
United States	Investigative Site	McAllen	Texas
United States	Investigative Site	Oak Park	Illinois
United States	Investigative Site	Orlando	Florida
United States	Investigative Site	Palm Beach Gardens	Florida
United States	Investigative Site	Phoenix	Arizona
United States	Investigative Site	Roanoke	Virginia
United States	Investigative Site	San Antonio	Texas
United States	Investigative Site	San Antonio	Texas
United States	Investigative Site	Sandy Springs	Georgia
United States	Investigative Site	Santa Ana	California
United States	Investigative Site	Shawnee Mission	Kansas
United States	Investigative Site	Springfield	Illinois
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	The Woodlands	Texas
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Tulsa	Oklahoma
United States	Investigative Site	Warrenton	Virginia
United States	Investigative Site	West Monroe	Louisiana
United States	Investigative Site	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean total number of supplemental aflibercept injections needed during the study	The mean total number of supplemental aflibercept injections needed during	Baseline to 18 months
Secondary	Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline	Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline	At 18 months
Secondary	Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)	Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)	Baseline to 18 months
Secondary	Mean change from baseline in Center Subfield Thickness (CST)	Mean change from baseline in Center Subfield Thickness (CST)	Baseline to 18 months
Secondary	Area under the curve (AUC) of Center Subfield Thickness (CST)	Area under the curve (AUC) of Center Subfield Thickness (CST)	Baseline to 18 months
Secondary	Mean change from baseline in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and subscale scores	The NEI VFQ-25 is a questionnaire that allows the individual to report on their level of visual function. Scores range from 0-100, with a score of 0 being the worst outcome and 100 being the best outcome.	At 18 months
Secondary	Safety Outcome Endpoints: The incidence and severity of treatment-related adverse events	The incidence and severity of treatment-related adverse events	Baseline to 18 months