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The Individually Marked Panretinal lasEr phoTokoagUlation for Proliferative Diabetic Retinopathy Study - DETECT (IMPETUS-D)

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ClinicalTrials.gov Identifier: NCT02157350
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
University of Southern Denmark
Moorfields Eye Hospital NHS Foundation Trust
National University, Singapore
Yamagata University
Information provided by (Responsible Party):
Thomas Lee Torp, Odense University Hospital

Brief Summary:
The purpose of this study is to determine the threshold level of proliferative diabetic retinopathy progression and regression after standard panretinal photocoagulation. Predictors of progression and regression will be identified which will include retinal vessel geometry (caliber, fractals and tortuosity), retinal vessel oxygen saturation and retinal areas of non-perfusion.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Procedure: Panretinal laser photocoagulation Phase 3

Detailed Description:

IMPETUS 2018 - DETECT is a six-month prospective study involving 90 treatment-naïve diabetes patients with proliferative diabetic retinopathy (PDR) referred for panretinal laser photocoagulation (PRP) treatment to the Department of Ophthalmology, Odense University Hospital between July 1st 2014 and June 30th 2015.

Project information will be given prior to the study to the ophthalmological departments of and to all private practicing ophthalmologists in the Region of Southern Denmark. Patients will at baseline have a standard examination that will include wide-field fundus photography, wide-field fluorescein angiography and spectral domain optical coherence tomography (SD-OCT) in order to confirm the diagnosis of PDR. If they meet the criteria of inclusion and not those of exclusion, they will be informed of the study verbally and writing and offered the chance to participate. Prior to the first session of PRP patients enrolled in the study will receive the rest of the baseline examinations including retinal oximetry. Standard PRP treatment will be given in two sessions by a trained doctor.

Patients will be re-examined at month 3 and 6 and progression/regression of PDR will be evaluated by measuring the amount of fluorescein leakage by wide-field fluorescein angiography at 1, 5 and 10 minutes. For patients with regression, supplementary PRP will be offered. After the final examination at month 6, patients will be referred back to their primary ophthalmologist.

A study nurse and a photographer will be assigned to the project. All examinations will be standardized and the study crew will be fully certified. Data will be analyzed with respect to the endpoint of the study (Stata 13, StataCorp, College Station, Texas) and also used to create the algorithm to be used for individualized treatment in IMPETUS 2018 - TREAT.

In the Region of Southern Denmark it is estimated that 200 treatment naïve patients with PDR will be referred for treatment annually. With an estimated participation rate of 50% and a subsequent dropout rate of 10%, IMPETUS 2018 - DETECT will include 90 patients. A traditional power calculation is not feasibly due to the design of the study with multiple outcomes studies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Panretinal photocoagulation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study to Identify Predictive Factors for Progression and Regression of Proliferative Diabetic Retinopathy in Patients Receiving Standard Panretinal Laser Photocoagulation.
Study Start Date : August 2014
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Panretinal Laser Photocoagulation
See interventional description.
Procedure: Panretinal laser photocoagulation
Panretinal photocoagulation. Laser energy is given to the retina in two sittings, carefully avoiding the macular. The energy are placed 2 to 3 disc diameters away from the macula and the disc outside the arcades and extended peripherally upto the equator and beyond.
Other Names:
  • NAVILAS laser
  • Retinal Laser Photocoagulation




Primary Outcome Measures :
  1. Proliferative diabetic retinopathy progression/regression. [ Time Frame: Change from baseline in proliferative diabetic retinopathy at 6 months ]
    Progression/regression of proliferative diabetic retinopathy will be evaluated by measuring the amount of fluorescein leakage by wide-field fluorescein angiography at 1, 5 and 10 minutes. These measurements will be performed at baseline, and during followup after panretinal photocoagulation (3 months and 6 months).


Secondary Outcome Measures :
  1. Retinal vessel geometry (caliber, fractals and tortuosity) [ Time Frame: Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation. ]

    Change in vessel geometry:

    Caliber: Using a computerised program - SIVA / IVAN. Fractals: Using a computerised program - SIVA. Tortuosity: Using a computerised program - SIVA



Other Outcome Measures:
  1. Retinal vessel oxygen saturation [ Time Frame: Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation. ]
    Oxymap T1 with the Oxymap Analyser. Non-invasively measuring the vessel saturation of both arterioles and venules in percentage.

  2. Retinal areas of non-perfusion. [ Time Frame: Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation. ]
    Using wide-field fluorescein angiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus
  • Proliferative diabetic retinopathy of one or both eyes

Exclusion Criteria:

  • Diabetic macular edema on current eye
  • Earlier PRP treatment on current eye
  • Cataract demanding treatment on current eye
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157350


Locations
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Denmark
Research Unit of Ophthalmology, Clinical Institute, University of Southern Denmark, Department of Ophthalmology, Odense University Hospital.
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Moorfields Eye Hospital NHS Foundation Trust
National University, Singapore
Yamagata University
Investigators
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Principal Investigator: Thomas L Torp, MD Research Unit of Ophthalmology, University of Southern Denmark
Study Director: Joakob Grauslund, DMSci, PhD Research Unit of Ophthalmology, University of Southern Denmark
Study Chair: Tundo Peto, PhD,FHCO NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS
Study Chair: Tien Y Wong, PhD Department of Ophthalmology National University of Singapore
Study Chair: Ryo Kawasaki, PhD Department of Public Health Ophthalmology, Yamagata
Additional Information:
Publications:

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Responsible Party: Thomas Lee Torp, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02157350    
Other Study ID Numbers: OUH-4202-ID-2018
S-20140046 ( Other Identifier: The Danish National Committee on Health Research Ethics )
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Thomas Lee Torp, Odense University Hospital:
Eye Diseases
Proliferative Diabetic Retinopathy
Retinal Vessel Geometry
Retinal Oxymetry
Retina Ischemia
Panretinal Photocoagulation
Lasers, Semiconductor
Fluorescein Angiography
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases