Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

NCT04977427 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: iRIS RB Number 021-167
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the effectiveness of Dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

Conditions

Cataract Diabetic; Macula Edema

Keywords

Prednisolone; Dextenza

Outcome Measures

Primary Outcomes (3)

• Optical Coherence Tomography (OCT)

  The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

  7 days

• Optical Coherence Tomography (OCT)

  The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

  14 days

• Optical Coherence Tomography (OCT)

  The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

  30 days

Secondary Outcomes (3)

• Macular Edema

  7 days

• Macular Edema

  14 days

• Macular Edema

  30 days

Study Arms (2)

Prednisolone Arm

ACTIVE COMPARATOR

Standard post-cataract surgery therapy arm; acts as control in each patient.

Drug: Prednisolone Acetate 1% Oph Susp

Dextenza Arm

ACTIVE COMPARATOR

Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

Dexamethasone inserted into lower punctum at the end of cataract surgery in order to control inflammation in the eye for the following 30 days after surgery.

Dextenza Arm

Prednisolone Acetate 1% Oph Susp DRUG

Standard Prednisolone taper following cataract surgery, QID for one week, followed by TID for one week, BID for one week, and QDaily for one week, then stop.

Prednisolone Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosed diabetes
• Patients must be undergoing cataract surgery in each eye
• Patients must have no worse than moderate nonproliferative diabetic retinopathy

You may not qualify if:

• Patients must not have any history of documented macular edema on OCT
• Patients must not have any macular edema on pre-op OCT
• Patients must not have any history of uveitis
• Patients must not have severe nonproliferative or proliferative diabetic retinopathy
• Patients with operative complications will be excluded from this study
• Patients with any active corneal disease, infectious or rheumatologic, will be excluded
• Patients must not be pregnant

Sponsors & Collaborators

• Baylor Research Institute: lead

MeSH Terms

Interventions

Calcium Dobesilate; prednisolone acetate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Unable to fully mask to investigator in order to maintain safety (must assess the investigational Dextenza insert and its position in the lower punctum at each office visit).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Fellow-Eye study design, in which one randomized eye in each patient undergoing bilateral cataract surgery receives standard prednisolone therapy, the other eye receiving the investigational Dextenza treatment.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 27, 2021
• Study Start: August 31, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: March 2, 2026

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share