Trial record 1 of 1 for:
01-20-005
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:
Alimera Sciences
Information provided by (Responsible Party):
Alimera Sciences
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
| 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 :
- 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 :
- 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
- 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)
- Mean change from baseline in Center Subfield Thickness (CST) [ Time Frame: Baseline to 18 months ]Mean change from baseline in Center Subfield Thickness (CST)
- 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)
- 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.
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Major Inclusion Criteria:
- Male or female subjects ≥18 years of age at the time of consent.
- 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.
- Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.
Major Exclusion Criteria:
- Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
- 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.
- Other conditions that can cause macular edema.
- 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.
-
Patients who received the following therapies in the study eye:
- Intravitreal or periocular steroids;
- Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
- 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
- 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).
- 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
| Contact: Ashley Gantt | 6785271332 | ashley.gantt@alimerasciences.com |
Locations
| 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
| 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 |
| 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:
|
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 |