Cooling Anesthesia for Intravitreal Injection (COOL-1)

A Phase I Dose Ranging Study Evaluating the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL 1)

The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration; Diabetic Macular Edema; Anesthesia, Local; Intravitreal Injection
• Intervention / Treatment: Device: Cooling Anesthesia

Detailed Description

Intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema. There is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. Current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia.

Recens Medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye This device cools to a temperature around -5 to -10 degrees Celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. The value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections.

This device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care.

This dose escalation study will test various temperatures and duration of temperatures to evaluate for safety as well as determine the optimal temperature for anesthesia during intravitreal injection.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • Texas
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women > 18 years old at screening visit.
• Men and women who are undergoing intravitreal injections in either one eye or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30 gauge needle.
• Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit.
• Subject is willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria:

• History of presence of scleromalacia
• Preexisting conjunctival, episcleral or scleral defects
• Less than 18 years of age
• Unable to provide informed consent
• Has received less than 3 injections in the study eye
• Active severe eye disease not controlled with artificial tears and requiring Restasis or Xiidra drops.
• History of Endophthalmitis with intravitreal injection
• History of uveitis
• History of retinal detachment in either eye
• History of vitrectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: -5 degrees Celsius for 10 seconds	Device: Cooling Anesthesia; Application of cooling anesthesia device prior to intravitreal injection
EXPERIMENTAL: -5 degrees Celsius for 20 seconds	Device: Cooling Anesthesia; Application of cooling anesthesia device prior to intravitreal injection
EXPERIMENTAL: -10 degrees Celsius for 10 seconds	Device: Cooling Anesthesia; Application of cooling anesthesia device prior to intravitreal injection
EXPERIMENTAL: -10 degrees Celsius for 20 seconds	Device: Cooling Anesthesia; Application of cooling anesthesia device prior to intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Pain	Pain as measured by the visual analogue scale (VAS). This was used in the previously presented SOLAR study (Clinical trials.gov, NCT01926977). Total range is 0-10, with 0 being no pain, and 10 being unbearable pain.	24-48 hours after injection
Number of patients with treatment adverse events as measured by slit lamp examination	Full slit lamp examination of anterior and posterior segment after intravitreal injection	30 minutes after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject response to needle penetration	subject response to needle penetration as evaluated by physician	Intraoperative (During injection)
Time to perform intravitreal injection	Time to perform injection, measured from beginning of anesthesia to intravitreal injection	Intraoperative (injection procedure)

Collaborators and Investigators

• Sponsor: Recens Medical, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2018
• Primary Completion (ACTUAL): April 26, 2019
• Study Completion (ACTUAL): April 26, 2019

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (ACTUAL): November 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: macular degeneration; anesthesia; diabetic macular edema; intravitreal injection
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: COOL-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Results of this study will be presented at a national meeting

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No