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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469595
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences

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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Iluvien 0.19 MG Drug Implant Drug: Aflibercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, masked, active-controlled, multi-center study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: ILUVIEN Arm
Intravitreal ILUVIEN
Drug: Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Other Name: ILUVIEN

Drug: Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Name: Eylea

Active Comparator: Aflibercept Arm
Intravitreal aflibercept
Drug: Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Name: Eylea




Primary Outcome Measures :
  1. The mean total number of supplemental aflibercept injections needed during the study [ Time Frame: Baseline to 18 months ]
    The mean total number of supplemental aflibercept injections needed during


Secondary Outcome Measures :
  1. Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline [ Time Frame: At 18 months ]
    Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline

  2. Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 18 months ]
    Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)

  3. Mean change from baseline in Center Subfield Thickness (CST) [ Time Frame: Baseline to 18 months ]
    Mean change from baseline in Center Subfield Thickness (CST)

  4. Area under the curve (AUC) of Center Subfield Thickness (CST) [ Time Frame: Baseline to 18 months ]
    Area under the curve (AUC) of Center Subfield Thickness (CST)

  5. Mean change from baseline in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and subscale scores [ Time Frame: At 18 months ]
    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.

  6. Safety Outcome Endpoints: The incidence and severity of treatment-related adverse events [ Time Frame: Baseline to 18 months ]
    The incidence and severity of treatment-related adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 last 12 months prior to screening:

    1. Intravitreal or periocular steroids in the study eye;
    2. Any intravitreal anti-VEGF [vascular endothelial growth factor (VEGF)] (including but not limited to bevacizumab, ranibizumab, or aflibercept);
    3. 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.
  6. 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).
  7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469595


Contacts
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Contact: Rachel Nelson 6785271317 rachel.nelson@alimerasciences.com
Contact: Liz Michael 6785271764 liz.michael@alimerasciences.com

Locations
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United States, Arizona
Investigative Site Recruiting
Phoenix, Arizona, United States, 85020
Contact: Study Coordinator         
Investigative Site Recruiting
Tucson, Arizona, United States, 85710
United States, California
Investigative Site Recruiting
Glendale, California, United States, 91203
Contact: Study Coordinator         
United States, Colorado
Investigative Site Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Study Coordinator         
United States, Florida
Investigative Site Recruiting
Clearwater, Florida, United States, 33761
Contact: Study Coordinator         
Investigative Site Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Investigative Site Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Investigative Site Recruiting
Lemont, Illinois, United States, 60439
Contact: Study Coordinator         
Investigative Site Recruiting
Oak Park, Illinois, United States, 60304
United States, Louisiana
Investigative Site Recruiting
West Monroe, Louisiana, United States, 71291
Contact: Study Coordinator         
United States, Missouri
Investigative Site Recruiting
Independence, Missouri, United States, 64055
Contact: Study Coordinator         
United States, Ohio
Investigative Site Recruiting
Beachwood, Ohio, United States, 44122
Contact: Study Coordinator         
Investigative Site Recruiting
Youngstown, Ohio, United States, 44122
Contact: Study Coordinator         
United States, Oklahoma
Investigative Site Recruiting
Tulsa, Oklahoma, United States, 74114
Contact: Study Coordinator         
United States, Texas
Investigative Site Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator         
Investigative Site Recruiting
Houston, Texas, United States, 77030
Investigative Site Recruiting
McAllen, Texas, United States, 78502
Contact: Study Coordinator         
Investigative Site Recruiting
San Antonio, Texas, United States, 72815
Investigative Site Recruiting
San Antonio, Texas, United States, 78240
Contact: Study Coordinator         
United States, Utah
Investigative Site Recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
Investigative Site Recruiting
Roanoke, Virginia, United States, 24018
Contact: Study Coordinator         
Investigative Site Recruiting
Warrenton, Virginia, United States, 20186
Contact: Study Coordinator         
Sponsors and Collaborators
Alimera Sciences
Investigators
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Study Chair: Samer Kaba, MD Alimera Sciences, Inc.
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Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT04469595    
Other Study ID Numbers: 01-20-005
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alimera Sciences:
DME
CI-DME
Diabetic Macular Edema
Diabetic Retinopathy
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs