Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections

NCT04563299 | Terminated Phase 4 FDA Drug

• 1 other identifier: DETeR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injection visits. Treatment will be rendered at each injection visit based on the individualized routine established anti-VEGF injection interval for each patient.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• Mean Change in Pain Scores

  As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain)

  As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3

Secondary Outcomes (10)

• Overall Proportion of Eyes with Absence of AC Cell/Flare (Score of 0)

  Assessed 3-6 days following Injection Visit 1, Injection Visit 2, and Injection Visit 3

• Proportion of eyes with absence of AC cells/flare (score of 0)

  Assessed at 3-6 days following Injection Visit 1, Injection Visit 2, and Injection Visit 3 by anti-VEGF type (ranibizumab, aflibercept, brolucizumab, or bevacizumab)

• Correlation of pain scale outcomes with absence or presence of AC cell count and flare scores

  Assessed at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3

• Mean Change in pain scores

  As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3

• Patient Comfort

  As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3

Study Arms (2)

Dextenza

EXPERIMENTAL

Dextenza (Dexamethasone Ophthalmic Insert 0.4 mg)

Drug: Dextenza 0.4Mg Ophthalmic Insert

Topical Corticosteroids

ACTIVE COMPARATOR

Topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week).

Drug: Prednisolone Acetate

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

All eyes (n=40) will receive anti-VEGF injections for the treatment of AMD, DME and macular edema secondary to RVO. Twenty eyes (one eye per patient) will be randomized to receive Dextenza. The contra-lateral eye (Control) will receive a sham dilation.

Dextenza

Prednisolone Acetate DRUG

All eyes (n=40) will receive anti-VEGF injections for the treatment of AMD, DME and macular edema secondary to RVO. Twenty eyes (one eye per patient) will be randomized to receive Dextenza. The contra-lateral eye (Control) will receive topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week).

Topical Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with neovascular AMD, DME or macular edema secondary to RVO undergoing anti-VEGF injections in both eyes.
• \> 18 years old
• Able to provide signed written consent prior to participation in any study-related procedures.

You may not qualify if:

• Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted)
• Use of any topical prescription ophthalmic medications (including cyclosporine \[Restasis®, Cequa®\] or topical lifitegrast \[Xiidra®\], steroids, nonsteroidal anti- inflammatory drugs \[NSAIDs\]within 7 days or during study period
• Participation in any drug or device clinical investigation within 30 days prior to study entry and/or during the study period.
• Anterior chamber cells present at time of enrollment
• History of cauterization of the punctum
• Any punctum inflammation or dacryocystitis

Sponsors & Collaborators

• Retina Vitreous Associates of Florida: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711-1141, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Calcium Dobesilate; prednisolone acetate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Eichenbaum, MD

  Retina Vitreous Associates of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the survey administrator are masked to the treatment assignment in each eye.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Within the respective cohorts, one eye per patient will be randomized to receive either an intracanalicular dexamethasone insert or the control treatment at each injection visit.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 24, 2020
• Study Start: December 9, 2020
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)