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Trial record 1 of 1 for:    01-20-005
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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 : January 6, 2022
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, 2024
Estimated Study Completion Date : June 30, 2024

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

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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 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.

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: Ashley Gantt 6785271332 ashley.gantt@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, 85704
United States, California
Investigative Site Recruiting
Beverly Hills, California, United States, 90211
Investigative Site Recruiting
Glendale, California, United States, 91203
Contact: Study Coordinator         
Investigative Site Recruiting
Laguna Hills, California, United States, 92653
Contact: Study Coordinator         
Investigative Site Recruiting
Santa Ana, California, United States, 92705
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
Investigative Site Recruiting
Palm Beach Gardens, Florida, United States, 33418
Contact: Study Coordinator         
Investigative Site Recruiting
Tampa, Florida, United States, 33609
United States, Georgia
Investigative Site Recruiting
Marietta, Georgia, United States, 30060
Investigative Site Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Investigative Site Recruiting
Elmhurst, Illinois, United States, 60126
Investigative Site Recruiting
Lemont, Illinois, United States, 60439
Contact: Study Coordinator         
Investigative Site Recruiting
Oak Park, Illinois, United States, 60304
Investigative Site Recruiting
Springfield, Illinois, United States, 62704
United States, Kansas
Investigative Site Recruiting
Leawood, Kansas, United States, 66211
Investigative Site Recruiting
Shawnee Mission, Kansas, United States, 66204
United States, Louisiana
Investigative Site Recruiting
West Monroe, Louisiana, United States, 71291
Contact: Study Coordinator         
United States, Maryland
Investigative Site Recruiting
Baltimore, Maryland, United States, 21237
Investigative Site Withdrawn
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Investigative Site Recruiting
Detroit, Michigan, United States, 48201
Contact: Study Coordinator         
Investigative Site Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Study Coordinator         
Investigative Site Withdrawn
Grand Rapids, Michigan, United States, 49546
Investigative Site Withdrawn
Jackson, Michigan, United States, 49201
United States, Missouri
Investigative Site Recruiting
Independence, Missouri, United States, 64055
Contact: Study Coordinator         
United States, New Jersey
Investigative Site Recruiting
Bloomfield, New Jersey, United States, 07003
Contact: Study Coordinator         
United States, Ohio
Investigative Site Recruiting
Beachwood, Ohio, United States, 44122
Contact: Study Coordinator         
Investigative Site Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Study Coordinator         
Investigative Site Recruiting
Cleveland, Ohio, United States, 22106
Contact: Study Coordinator         
Investigative Site Recruiting
Youngstown, Ohio, United States, 44505
Contact: Study Coordinator         
United States, Oklahoma
Investigative Site Recruiting
Tulsa, Oklahoma, United States, 74114
Contact: Study Coordinator         
United States, Pennsylvania
Investigative Site Recruiting
Erie, Pennsylvania, United States, 16507
Contact: Study Coordinator         
United States, South Carolina
Investigative Site Active, not recruiting
Columbia, South Carolina, United States, 29169
United States, South Dakota
Investigative Site Withdrawn
Rapid City, South Dakota, United States, 57701
United States, Texas
Investigative Site Recruiting
Dallas, Texas, United States, 75231
Contact: Study Coordinator         
Investigative Site Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator         
Investigative Site Recruiting
McAllen, Texas, United States, 78503
Contact: Study Coordinator         
Investigative Site Recruiting
San Antonio, Texas, United States, 72815
Investigative Site Recruiting
San Antonio, Texas, United States, 78240
Contact: Study Coordinator         
Investigative Site Recruiting
San Antonio, Texas, United States, 78240
Investigative Site Recruiting
The Woodlands, Texas, United States, 77384
United States, Utah
Investigative Site Withdrawn
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
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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: January 6, 2022
Last Verified: January 2022
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
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists