NEW DAY: A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
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 |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: ILUVIEN Arm Intravitreal ILUVIEN |
Drug: Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Other Names:
Drug: Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Names:
|
Active Comparator: Aflibercept Arm Intravitreal aflibercept |
Drug: Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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)
- Mean change from baseline in Center Subfield Thickness (CST) [Baseline to 18 months]
Mean change from baseline in Center Subfield Thickness (CST)
- Area under the curve (AUC) of Center Subfield Thickness (CST) [Baseline to 18 months]
Area under the curve (AUC) of Center Subfield Thickness (CST)
- 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.
- 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
Major Inclusion Criteria:
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Male or female subjects ≥18 years of age at the time of consent.
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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.
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Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.
Major Exclusion Criteria:
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Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
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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.
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Other conditions that can cause macular edema.
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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.
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Patients who received the following therapies in the study eye:
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Intravitreal or periocular steroids;
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Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
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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
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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).
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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 | |
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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.- 01-20-005