DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedAugust 11, 2020
August 1, 2020
1.5 years
April 10, 2020
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 7 on Optical Coherence Tomography at Day 7 by a masked grader.
7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on optical coherence tomography at Day 30 by a masked grader.
30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 60 and on optical coherence tomography at Day 60 by a masked grader.
60 days
Secondary Outcomes (14)
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
7days
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
30 days
Incidence of central subfield thickness (CST) at Day 60 post op as seen on optical coherence tomography (OCT)
60 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
7 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
30 days
- +9 more secondary outcomes
Study Arms (2)
Dextenza
EXPERIMENTALSustained release Dexamethasone 0.4mg
Prednisolone Acetate 1%
ACTIVE COMPARATORPrednisolone Acetate Ophthalmic drops
Interventions
Prednisolone Acetate 1% ophthalmic drops
Eligibility Criteria
You may qualify if:
- Binocular
- \>18 years old
- Any level of Background Diabetic Retinopathy
- Cataract surgery candidate in each eye
- Pre-operative OCT and Fluorescein Angiography showing no Macular edema
You may not qualify if:
- Participant cannot complete second eye operation within 60 days of the first cataract surgery
- Maintains regular use of systemic or ocular steroids at time of enrollment
- Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
- Anterior chamber cells present at time of enrollment
- Recent febrile illness that precludes or delays participation for 90 days
- Pregnancy or lactation
- Known allergy to dexamethasone
- Known allergy to prednisolone
- Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.
- Posterior capsule rupture or other intraoperative complication in first eye operated on
- Amblyopia
- Anti-VEGF injections within 6 months prior to surgery day.
- Intraocular steroid injection within 6 months prior to surgery day.
- Intraocular surgeries within 6 months prior to surgery day.
- Laser photocoagulation within 30 days prior to surgery day.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Consultants of the Capital Region
Troy, New York, 12180, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Feldman, MD
Ophthalmic Consultants of the Capital Region
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2020
First Posted
April 24, 2020
Study Start
August 7, 2020
Primary Completion
February 1, 2022
Study Completion
March 1, 2022
Last Updated
August 11, 2020
Record last verified: 2020-08