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出境医 / 临床实验 / Nailfold Capillary Blood Flow With Latanoprost Bunod

Nailfold Capillary Blood Flow With Latanoprost Bunod

Study Description
Brief Summary:
The purpose of this study is to look at the relationship of small blood vessels irregularities observed with an imaging system called video nailfold capillaroscopy in people with primary open-angle glaucoma. Nailfold capillaroscopy (NFC) is a video camera with a magnifying lens used for studying the movement of blood in small blood vessels. It is simple, safe and does not penetrate the skin. The skin fold that is at the tip of the finder is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Drug: Latanoprost 0.005% Drug: Latanoprost bunod 0.024% Drug: Normal saline 0.9% Diagnostic Test: Nailfold capillaroscopy Phase 4

Detailed Description:

In this study, the study team investigates the effect of topically-applied latanoprostene bunod (LTB) on the blood flow at the nailfold of the 4th finger in patients with primary open angle glaucoma. LTB is a new anti-glaucoma eye drop which received FDA clearance in early November 2017. It has two components: the prostaglandin analog (PGA) which decreases intraocular pressure (IOP) by enhancing the drainage of the aqueous (the fluid in the front part of the eye) from the eye, and the nitric oxide (NO) moiety which naturally dilates arteries in the body. The capillaries at the nailfold are comparable to those of the optic nerve head, which makes them a reasonable surrogate for evaluation of the effect of LTB on the blood flow. Therefore, this study may provide indirect evidence for the beneficial effect of LTB on blood flow to optic nerve which can potentially save the optic nerve from glaucomatous damage. Primary open angle glaucoma is a progressive condition and is the most common cause of irreversible blindness worldwide. Primary open angle glaucoma (POAG) is a subset of the glaucomas defined by an open, normal appearing anterior chamber angle and raised intraocular pressure (IOP), with no other underlying disease.

In addition to LTB, the study team will use latanoprost (L), an-FDA approved PGA anti-glaucoma eye drop and normal saline (NS: the physiologic solution composed of 0.9% salt and water), as controls to make sure the effects of LPB on nail fold capillary blood flow is not due to its PGA (as L is) or due to the placebo effect (as NS is).

This study may also serve as background information for the development of new anti-glaucoma medications which can be injected into the eye to facilitate blood flow to the optic nerve.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Patients will have baseline NFC blood flow measurements after application of cedar oil. Then the study team will use NF application of either normal saline, latanoprost 0.005% or LTB 0.024% in random sequence. The patient and imager will know which study article is applied. NFC blood flow will be remeasured after 15 minutes. Preliminary data on controls suggests that 15 minutes is sufficient time to see a change in blood flow. NF article application will occur on a specially designed well applied to the 4th digit of the non-dominant hand. Two masked observers will evaluate NFC blood flow.
Primary Purpose: Basic Science
Official Title: Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow
Actual Study Start Date : August 15, 2019
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Latanoprost 0.005%
Latanoprost 0.005% drops to the nailfold.
 Drug: Latanoprost 0.005%
Latanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
Other Name: Xalatan

Diagnostic Test: Nailfold capillaroscopy
An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger.
Other Name: NFC
Experimental: Latanoprost bunod 0.024%
Latanoprost bunod 0.024% drops to the nailfold.
 Drug: Latanoprost bunod 0.024%
Latanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
Other Names:
  • Vyzulta
  • LTB

Diagnostic Test: Nailfold capillaroscopy
An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger.
Other Name: NFC
Placebo Comparator: Normal saline 0.9%
Normal saline 0.9% to the nailfold.
 Drug: Normal saline 0.9%
Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.

Diagnostic Test: Nailfold capillaroscopy
An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger.
Other Name: NFC
Outcome Measures
Primary Outcome Measures :
  1. Change in NFC blood flow [ Time Frame: baseline and 15 minutes ]
    The change in NFC blood flow 15 minutes after NF application to the 4th digit of the nondominant hand at 15 minutes as compared to baseline.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 years old to 80 years old
  • All participants will have open angles and no signs of secondary glaucoma such as exfoliation syndrome
  • Untreated intraocular pressure (IOP) may be #21mmHg or #21mmHg in both eyes
  • The cup-to-disc ratio (CDR) #0.6 in both eyes and CDR asymmetry #0.2.
  • POAG patients will have reliable Humphrey Visual Field (HVF) loss consistent with optic nerve damage
  • POAG patients can have any stage of POAG and be on any form of treatment for their disease.
  • Willingness to sign informed consent and comply with study procedures.

Exclusion Criteria:

  • History of non-POAG forms of glaucoma
  • Pregnancy
  • Inability to give informed consent
Contacts and Locations

Locations
Layout table for location information
United States, New York
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States, 10003
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Robert Ritch, MD Icahn School of Medicine at Mount Sinai
Tracking Information
First Submitted Date  ICMJE May 12, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date December 7, 2020
Actual Study Start Date  ICMJE August 15, 2019
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2019) 		Change in NFC blood flow [ Time Frame: baseline and 15 minutes ]
The change in NFC blood flow 15 minutes after NF application to the 4th digit of the nondominant hand at 15 minutes as compared to baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nailfold Capillary Blood Flow With Latanoprost Bunod
Official Title  ICMJE Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow
Brief Summary The purpose of this study is to look at the relationship of small blood vessels irregularities observed with an imaging system called video nailfold capillaroscopy in people with primary open-angle glaucoma. Nailfold capillaroscopy (NFC) is a video camera with a magnifying lens used for studying the movement of blood in small blood vessels. It is simple, safe and does not penetrate the skin. The skin fold that is at the tip of the finder is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.
Detailed Description

In this study, the study team investigates the effect of topically-applied latanoprostene bunod (LTB) on the blood flow at the nailfold of the 4th finger in patients with primary open angle glaucoma. LTB is a new anti-glaucoma eye drop which received FDA clearance in early November 2017. It has two components: the prostaglandin analog (PGA) which decreases intraocular pressure (IOP) by enhancing the drainage of the aqueous (the fluid in the front part of the eye) from the eye, and the nitric oxide (NO) moiety which naturally dilates arteries in the body. The capillaries at the nailfold are comparable to those of the optic nerve head, which makes them a reasonable surrogate for evaluation of the effect of LTB on the blood flow. Therefore, this study may provide indirect evidence for the beneficial effect of LTB on blood flow to optic nerve which can potentially save the optic nerve from glaucomatous damage. Primary open angle glaucoma is a progressive condition and is the most common cause of irreversible blindness worldwide. Primary open angle glaucoma (POAG) is a subset of the glaucomas defined by an open, normal appearing anterior chamber angle and raised intraocular pressure (IOP), with no other underlying disease.

In addition to LTB, the study team will use latanoprost (L), an-FDA approved PGA anti-glaucoma eye drop and normal saline (NS: the physiologic solution composed of 0.9% salt and water), as controls to make sure the effects of LPB on nail fold capillary blood flow is not due to its PGA (as L is) or due to the placebo effect (as NS is).

This study may also serve as background information for the development of new anti-glaucoma medications which can be injected into the eye to facilitate blood flow to the optic nerve.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Patients will have baseline NFC blood flow measurements after application of cedar oil. Then the study team will use NF application of either normal saline, latanoprost 0.005% or LTB 0.024% in random sequence. The patient and imager will know which study article is applied. NFC blood flow will be remeasured after 15 minutes. Preliminary data on controls suggests that 15 minutes is sufficient time to see a change in blood flow. NF article application will occur on a specially designed well applied to the 4th digit of the non-dominant hand. Two masked observers will evaluate NFC blood flow.
Primary Purpose: Basic Science
Condition  ICMJE Glaucoma, Open-Angle
Intervention  ICMJE
  • Drug: Latanoprost 0.005%
    Latanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
    Other Name: Xalatan
  • Drug: Latanoprost bunod 0.024%
    Latanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
    Other Names:
    • Vyzulta
    • LTB
  • Drug: Normal saline 0.9%
    Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
  • Diagnostic Test: Nailfold capillaroscopy
    An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger.
    Other Name: NFC
Study Arms  ICMJE
  • Active Comparator: Latanoprost 0.005%
    Latanoprost 0.005% drops to the nailfold.
    Interventions:
    • Drug: Latanoprost 0.005%
    • Diagnostic Test: Nailfold capillaroscopy
  • Experimental: Latanoprost bunod 0.024%
    Latanoprost bunod 0.024% drops to the nailfold.
    Interventions:
    • Drug: Latanoprost bunod 0.024%
    • Diagnostic Test: Nailfold capillaroscopy
  • Placebo Comparator: Normal saline 0.9%
    Normal saline 0.9% to the nailfold.
    Interventions:
    • Drug: Normal saline 0.9%
    • Diagnostic Test: Nailfold capillaroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2020) 		47
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2019) 		60
Actual Study Completion Date  ICMJE October 1, 2020
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 40 years old to 80 years old
  • All participants will have open angles and no signs of secondary glaucoma such as exfoliation syndrome
  • Untreated intraocular pressure (IOP) may be #21mmHg or #21mmHg in both eyes
  • The cup-to-disc ratio (CDR) #0.6 in both eyes and CDR asymmetry #0.2.
  • POAG patients will have reliable Humphrey Visual Field (HVF) loss consistent with optic nerve damage
  • POAG patients can have any stage of POAG and be on any form of treatment for their disease.
  • Willingness to sign informed consent and comply with study procedures.

Exclusion Criteria:

  • History of non-POAG forms of glaucoma
  • Pregnancy
  • Inability to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949244
Other Study ID Numbers  ICMJE GCO 18-2686
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Results of the study will be shared as publications in peer-reviewed journals and at scientific meetings. All data to be shared will be de-identified. Study subjects may request to learn the results of the study, which will be provided orally by the study staff, or they will be referred to any publications.
Time Frame: Results will be shared upon completion of the study.
Responsible Party James Tsai, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Ritch, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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