COOL-2: Long Term Safety of Cooling Anesthesia for Intravitreal Injection

Sponsor

Recens Medical, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03956797

Collaborator

(none)

Enrollment

Locations

Arms

20.6

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local Intravitreal Injection Macular Edema Macular Degeneration Diabetic Retinopathy Diabetic Macular Edema	Device: Recens Cooling Anesthesia Device	Phase 1/Phase 2

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 -15 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

A long term safety, dose escalation study design of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection.A long term safety, dose escalation study design of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Long Term Evaluation of the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL-2)

Actual Study Start Date :

Apr 15, 2019

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: -15 degrees Celsius for 10 seconds Cooling anesthesia device applied to the eye at -15 degrees Celsius for 10 seconds.	Device: Recens Cooling Anesthesia Device Application of cooling anesthesia device prior to intravitreal injection
Experimental: -15 degrees Celsius for 15 seconds Cooling anesthesia device applied to the eye at -15 degrees Celsius for 15 seconds.	Device: Recens Cooling Anesthesia Device Application of cooling anesthesia device prior to intravitreal injection

Arm

Intervention/Treatment

Experimental: -15 degrees Celsius for 10 seconds

Cooling anesthesia device applied to the eye at -15 degrees Celsius for 10 seconds.

Device: Recens Cooling Anesthesia Device

Application of cooling anesthesia device prior to intravitreal injection

Experimental: -15 degrees Celsius for 15 seconds

Cooling anesthesia device applied to the eye at -15 degrees Celsius for 15 seconds.

Device: Recens Cooling Anesthesia Device

Application of cooling anesthesia device prior to intravitreal injection

Outcome Measures

Primary Outcome Measures

Pain of Intravitreal Injection: VAS [Immediately after injection]
Pain of intravitreal injection as measured by 10-point visual analog scale (VAS) (0 meaning no pain, 10 meaning the most severe pain).
Incidence of Anesthesia-Related Adverse Events [30 minutes after injection]
% of patients that experience cooling anesthesia device-related adverse events, as assessed by anterior segment and posterior segment examination.

Secondary Outcome Measures

Patient Movement During Intravitreal Injection [During injection]
Physician's evaluation of the subject's movement during the intravitreal injection procedure in response to needle penetration (0 = no movement, 1 = mild movement, 2 = marked movement).
Time [Time for entire intravitreal injection procedure]
Recording of the time it takes to perform intravitreal injection procedure.
Patient Anesthetic Preference [24-48 hours after injection]
Patient response to a questionnaire asking which method of anesthesia they prefer: standard of care or the cooling anesthesia device.
Pain of Intravitreal Injection (Follow-Up): VAS [24-48 hours after injection]
Pain of intravitreal injection as measured by 10-point visual analog scale (0 meaning no pain, 10 meaning the most severe pain) during follow-up phone call.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 other prescription drugs for dry eye.
History of Endophthalmitis with intravitreal injection
History of uveitis
History of retinal detachment in either eye
History of vitrectomy
Subjects who received administration of cooling anesthesia as part of the COOL-1 study will not be excluded and are eligible to participate in this study.