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

Sponsor
Alimera Sciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04469595
Collaborator
(none)
300
46
2
46
6.5
0.1

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, masked, active-controlled, multi-center studyRandomized, 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 :
Aug 31, 2020
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ILUVIEN Arm

Intravitreal ILUVIEN

Drug: Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Other Names:
  • ILUVIEN
  • Drug: Aflibercept
    2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
    Other Names:
  • Eylea
  • Active Comparator: Aflibercept Arm

    Intravitreal aflibercept

    Drug: Aflibercept
    2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
    Other Names:
  • Eylea
  • Outcome Measures

    Primary Outcome Measures

    1. The mean total number of supplemental aflibercept injections needed during the study [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 [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) [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) [Baseline to 18 months]

      Mean change from baseline in Center Subfield Thickness (CST)

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

      The incidence and severity of treatment-related adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    6. Intravitreal or periocular steroids;

    7. Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit

    8. 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

    9. 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).

    10. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigative Site Phoenix Arizona United States 85020
    2 Investigative Site Tucson Arizona United States 85704
    3 Investigative Site Beverly Hills California United States 90211
    4 Investigative Site Glendale California United States 91203
    5 Investigative Site Laguna Hills California United States 92653
    6 Investigative Site Santa Ana California United States 92705
    7 Investigative Site Colorado Springs Colorado United States 80909
    8 Investigative Site Clearwater Florida United States 33761
    9 Investigative Site Orlando Florida United States 32806
    10 Investigative Site Palm Beach Gardens Florida United States 33418
    11 Investigative Site Tampa Florida United States 33609
    12 Investigative Site Marietta Georgia United States 30060
    13 Investigative Site Sandy Springs Georgia United States 30328
    14 Investigative Site Elmhurst Illinois United States 60126
    15 Investigative Site Lemont Illinois United States 60439
    16 Investigative Site Oak Park Illinois United States 60304
    17 Investigative Site Springfield Illinois United States 62704
    18 Investigative Site Leawood Kansas United States 66211
    19 Investigative Site Shawnee Mission Kansas United States 66204
    20 Investigative Site West Monroe Louisiana United States 71291
    21 Investigative Site Baltimore Maryland United States 21237
    22 Investigative Site Chevy Chase Maryland United States 20815
    23 Investigative Site Detroit Michigan United States 48201
    24 Investigative Site Grand Blanc Michigan United States 48439
    25 Investigative Site Grand Rapids Michigan United States 49546
    26 Investigative Site Jackson Michigan United States 49201
    27 Investigative Site Independence Missouri United States 64055
    28 Investigative Site Bloomfield New Jersey United States 07003
    29 Investigative Site Beachwood Ohio United States 44122
    30 Investigative Site Cincinnati Ohio United States 45242
    31 Investigative Site Cleveland Ohio United States 22106
    32 Investigative Site Youngstown Ohio United States 44505
    33 Investigative Site Tulsa Oklahoma United States 74114
    34 Investigative Site Erie Pennsylvania United States 16507
    35 Investigative Site Columbia South Carolina United States 29169
    36 Investigative Site Rapid City South Dakota United States 57701
    37 Investigative Site Dallas Texas United States 75231
    38 Investigative Site Houston Texas United States 77030
    39 Investigative Site McAllen Texas United States 78503
    40 Investigative Site San Antonio Texas United States 72815
    41 Investigative Site San Antonio Texas United States 78240
    42 Investigative Site San Antonio Texas United States 78240
    43 Investigative Site The Woodlands Texas United States 77384
    44 Investigative Site Salt Lake City Utah United States 84107
    45 Investigative Site Roanoke Virginia United States 24018
    46 Investigative Site Warrenton Virginia United States 20186

    Sponsors and Collaborators

    • Alimera Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alimera Sciences
    ClinicalTrials.gov Identifier:
    NCT04469595
    Other Study ID Numbers:
    • 01-20-005
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2022