INtravitreal and Aqueous Dexamethasone Levels After DEXtenza (INDEX)

Nathan Steinle

Status and phase: Unknown; Phase 4

Conditions: Ocular Disease Requiring Surgery

Treatments: Drug: DEXTENZA®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04529512

INDEX

Details and patient eligibility

About

A prospective, open-label, interventional study to determine intraocular concentration levels of dexamethasone following use of the DEXTENZA® implant.

Full description

On December 3rd, 2018, DEXTENZA® was approved by the FDA for the treatment of ocular pain following ophthalmic surgery. On June 21st, 2019, the FDA approved a Supplemental New Drug Application (sNDA) for DEXTENZA® to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication.

DEXTENZA® is a corticosteroid implant indicated for the treatment of ocular pain following ophthalmic surgery. DEXTENZA® is inserted into the lower lacrimal punctum into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA® releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA® is preservative free, resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert, if necessary.

In the two phase III trials, patients were given DEXTENZA® or its vehicle immediately after cataract surgery. In the first study, 80 percent of DEXTENZA®-treated patients (n=164) were pain-free at the eighth day compared to 43 percent of vehicle-treated patients (n=83) (p<0.0001). In the second trial, 77 percent of patients on active drug (n=161) were pain-free at the eighth day vs. 59 percent of those on the vehicle.1

Safety was assessed from the three Phase 3 clinical trials and a Phase 2 clinical trial.1,2 Overall, 567 subjects were exposed to DEXTENZA®. The most common ocular adverse reactions in subjects treated with DEXTENZA® were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

Though DEXTENZA has been found to be safe and effective, it is a relatively new therapy and a randomized prospective study looking at dexamethasone and pain levels following retinal surgery has not yet been done. The purpose of this study is to provide real-world intraocular dexamethasone concentration levels in subjects implanted with DEXTENZA as well as to confirm the reduction of pain in patients undergoing retinal surgery is the same as subjects who underwent cataract surgery in the phase III studies.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of California Retina Consultants undergoing vitrectomy surgery
2. Must be 18 years old or older
3. Must be able to provide consent

Exclusion criteria

1. Must not have been treated with DEXTENZA® prior to joining the study.

2. May not have more than one DEXTENZA® implant.

3. May not be currently using an dexamethasone product during the course of the study or within 4 weeks prior to enrolling in the study.

4. Subject has active corneal, conjunctival or canalicular infections, including:

   i. Epithelial herpes simplex keratitis (dendritic keratitis)

   ii. Vaccini

   iii. Varicella

   iv. Mycobacterial infections

   v. Fungal diseases of the eye

   vi. Dacryocystitis

5. Any abnormal lid or punctum anatomy that would preclude or make inappropriate the placement of the insert (e.g., severe ectropion or punctal stenosis).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Receiving DEXTENZA® 1-3 days prior to surgery

Experimental group

Description:

Participants to receive DEXTENZA® 1-3 days prior to surgery

Treatment:

Drug: DEXTENZA®

Receiving DEXTENZA® 1-2 weeks prior to surgery

Experimental group

Description:

Participants to receive DEXTENZA® 1-2 weeks prior to surgery

Treatment:

Drug: DEXTENZA®

Receiving DEXTENZA® 1 month prior to surgery

Experimental group

Description:

Participants to receive DEXTENZA® 1 month prior to surgery

Treatment:

Drug: DEXTENZA®

Not receiving the DEXTENZA® implant

No Intervention group

Description:

Participants will not receive the DEXTENZA® implant