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Monoclonal Antibodies
Dexamethasone Implant vs Aflibercept for Diabetic Macular Edema (PRECISION Trial)
Phase 4
Waitlist Available
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
PRECISION Trial Summary
This trial is comparing the dexamethasone implant to intravitreal aflibercept for the treatment of diabetic macular edema.
Eligible Conditions
- Diabetic Macular Edema
PRECISION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The mean change in central subfield thickness
Secondary outcome measures
Change in BCVA
Change in DRSS
Change in ellipsoid zone integrity
+6 morePRECISION Trial Design
2Treatment groups
Active Control
Group I: Group A: Intravitreal Dexamethasone ImplantActive Control2 Interventions
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Group II: Group B: Intravitreal AfliberceptActive Control1 Intervention
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,027 Previous Clinical Trials
1,364,255 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,546 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Group A: Intravitreal Dexamethasone Implant
- Group 2: Group B: Intravitreal Aflibercept
Awards:
This trial has 5 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being allowed to partake in this clinical trial?
"That is correct. The trials website indicates that the study is actively looking for participants. The original posting date was April 10th, 2020, and the most recent update was on October 31st, 2022. Currently, the study is enrolling 50 patients at a single location."
Answered by AI
Has the FDA cleared dexamethasone implants for use inside the eye?
"Group A: Intravitreal Dexamethasone Implant has been approved, thus signifying its safety with a score of 3."
Answered by AI
What medical conditions does Group A: Intravitreal Dexamethasone Implant help to alleviate?
"ophthalmia, sympathetic can be managed with Group A: Intravitreal Dexamethasone Implant. Additionally, this treatment course can also help patients with branch retinal vein occlusion, communicable diseases, and macular edema."
Answered by AI
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