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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04563299
Other study ID # DETeR
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date December 9, 2020
Est. completion date February 14, 2023

Study information

Verified date February 2023
Source Retina Vitreous Associates of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. 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. Cohorts are as follows: Cohort 1: Total N= 40 eyes (20 patients). Twenty eyes (one eye per patient) will be randomized to receive an intracanalicular dexamethasone insert. The contra-lateral eye (Control) will receive a sham dilation. Cohort 2: Total N= 40 eyes (20 patients). Twenty eyes (one eye per patient) will be randomized to receive an intracanalicular dexamethasone insert. 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). In eyes randomized to either DEXTENZA or sham dilation, DEXTENZA insertion or sham dilation will be performed prior to injection. In eyes randomized to either DEXTNEZA or topical steroids, eyes randomized to DEXTENZA will receive insertion prior to injection. Eyes randomized to topical steroid therapy (Control) will receive 1 drop of prednisolone acetate 1% pre-injection and the remaining 3 drops of prednisolone acetate 1% post injection. Control eyes will follow tapered dosing over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week) to ensure dose matching between DEXTENZA and Control in Cohort 1. Pain will be rated at 6 time points: (1) prior to any treatment, (2) after anesthesia, (3) after intravitreal injection, (4) 6 hours by telephone (+/- 2 hours), (5) 24 hours by telephone (+/-3 hours) and (6) 3-6 days at assessment visit. Pain will be evaluated by survey administrators masked to treatment assignment. Patient comfort (right eye vs left eye) will be assessed at each patient visit by masked survey administrator. Anterior cell count and anterior cell flare assessment will be conducted at 3-6 days following each intravitreal injection visit. There will be a final patient preference survey performed.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date February 14, 2023
Est. primary completion date February 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: - 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. Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dextenza 0.4Mg Ophthalmic Insert
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.
Prednisolone Acetate
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).

Locations

Country Name City State
United States Retina Vitreous Associates of Florida Saint Petersburg Florida

Sponsors (2)

Lead Sponsor Collaborator
Retina Vitreous Associates of Florida Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Proportion of Eyes with Absence of AC Cell/Flare (Score of 0) As measured using SUN criteria Assessed 3-6 days following Injection Visit 1, Injection Visit 2, and Injection Visit 3
Secondary Proportion of eyes with absence of AC cells/flare (score of 0) As measured using SUN criteria 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)
Secondary Correlation of pain scale outcomes with absence or presence of AC cell count and flare scores As measured using 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
Secondary 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 Patient Comfort As measured by masked survey administrator 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 Mean Change in Tear Break-up Time As measured by the tear break-up time As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks)
Secondary Mean Change in Snellen and Pinhole Acuity As measured by the ETDRS visual acuity chart As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks)
Secondary Mean change in IOP As measured by using a Tono-pen As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks)
Secondary Patient Preference As measured by modified COMTOL As assessed at the Final Post-Injection Follow-up Visit (up to 24 weeks)
Secondary Incidence and severity of adverse events As measured by the incidence and severity of adverse events As assessed at Baseline, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks)
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