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The Individually-Marked Panretinal Laser phoTocoagulation for Proliferative Diabetic Retinopathy Study (TREAT)

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ClinicalTrials.gov Identifier: NCT03113006
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
University of Southern Denmark
Velux Fonden
Information provided by (Responsible Party):
Anna Stage Vergmann, Odense University Hospital

Brief Summary:

Background Diabetic eye disease is the most frequent complication among the 320,000 Danes with diabetes. The formation of new vessels (PDR) in the inner part of the eye (retina) is a feared complication and a leading cause of blindness, since these vessels are fragile and often cause bleeding within the eye. Peripheral retinal laser treatment (PRP) halves the risk of blindness, but often comes with a high prize. The peripheral part of the retina is responsible for the visual field and the night vision, and PRP limits these abilities (i.e. loss of driving license).

The technique of PRP has principally been the same for the past 40 years with standard treatment given for all patients. With this one size fits all approach, a substantial number of patients will either be treated too much or too little. Too little treatment is inefficient, and disease progression may occur. Excessive treatment may cause side effects like loss of visual fields and decreased night vision. Therefore, it is important to test if treatment can be applied on an individual basis to give high efficacy treatment with minimal side effects.

IMPETUS 2018 - TREAT is the second of two studies aimed at making an individual design for retinal laser treatment. In IMPETUS 2018 - DETECT the investigators demonstrated that non-invasive examinations of the oxygen level and measurements of the retinal vascular tree provide important information of individual treatment response. For instance, if standard PRP led to three per cent higher retinal oxygen saturation, there was a 4-fold risk of disease progression despite treatment. Hence, such a patient would benefit from more treatment to avoid blindness. With these observations at hand, the investigators want to compare a less invasive treatment (individualized laser treatment) against the standard PRP.

Another essential aspect in the treatment of PDR is to be able to give the right diagnosis and to evaluate the efficacy of laser treatment. So far, this has been performed by fluorescein angiography. However, this examination are highly person-dependent and unpleasant to patients, and a more objective approach is needed. Optical coherent tomography angiography (OCT-A) is a quick, noninvasive scanning of the retina which is ideal to visualize moving objects like blood within the retinal vessels. The method has been successfully implemented in a number of retinal diseases, but it has never been validated in PDR.

Standard PRP is often performed in 3-4 sessions. However, it may be painful, and patients sometimes choose not to complete all sessions after the initial treatment has been given. There is insufficient knowledge of the patient-barriers to treatment, and it is important to address these in an individualized treatment design.

Aim In this 6-month 1:1 randomized, prospective study the investigators want to investigate 1) whether individualized retinal laser treatment compared with standard PRP has the same efficacy but less side effects, 2) whether OCT-A can be used as an objective marker for disease activity, and 3) to obtain a better understanding of patient-reported barriers to standard laser treatment PRP and whether these can be addressed with personalized retinal laser treatment.

Setup Fifty eight consecutively recruited patients (1 May 2017 - 30 April 2018) with newly diagnosed PDR referred to the Department of Ophthalmology, OUH, and randomly assigned to standard PRP (n=29) or individualized laser treatment (n=29).

Intervention Standard laser treatment is performed in all four quadrants of the retina. Individualized laser treatment is only performed in the part(s) of the retina with proliferation(s).

Both treatments are carried out at baseline (BL), and additional treatment is given at month three (M3) and/or (M6), if necessary.

Investigations Retinal digital images, fluorescein angiography, OCT-A (BL, M3, M6). Test of visual fields, dark adaptation and quality of life (BL, M6). Semi-structured interview will be performed with five patients who have received PRP in one eye and individualized laser treatment in the other eye. This will address treatment experience, potential barriers to treatment, etc.

What to measure:

Differences in need for retreatment, night blindness, visual fields, visual acuity, bleeding in the eye, surgery, and quality of life between the groups.


Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy PDR Diabetes Procedure: Panretinal Photocoagulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Individually-Marked Panretinal Laser phoTocoagulation for Proliferative Diabetic Retinopathy Study: IMPETUS 2018 - TREAT
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Panretinal Photocoagulation
Localized to all four retinal quadrants.
Procedure: Panretinal Photocoagulation
Panretinal laser treatment of the retina in patients with proliferative diabetic retinopathy.
Other Name: PRP

Experimental: Individ. Panretinal Photocoagulation
Localized to only the affected quadrants.
Procedure: Panretinal Photocoagulation
Panretinal laser treatment of the retina in patients with proliferative diabetic retinopathy.
Other Name: PRP




Primary Outcome Measures :
  1. Need for retreatment between the groups [ Time Frame: At month 3 and 6 ]
    Change in the progression of PDR, hence the difference in the need for retreatment between the standard laser treatment group vs. the individualized laser treatment group.

  2. Loss of visual fields between the groups [ Time Frame: From baseline to month 6 ]
    Loss of visual field between the standard laser treatment group vs. the individualized laser treatment group.

  3. Change in dark adaptation between the groups [ Time Frame: From baseline to month 6 ]
    Change in dark adaptation between the standard laser treatment group vs. the individualized laser treatment group.

  4. Sensitivity and specificity of OCT angiography as an expression of disease activity in PDR [ Time Frame: At month 6 ]
    The specificity and sensitivity of OCT-A in detecting progression in PDR


Secondary Outcome Measures :
  1. Change in visual acuity between the groups [ Time Frame: From baseline to month 6 ]
    Change in visual acuity between the standard laser treatment group vs. the individualized laser treatment group.

  2. Difference in proportion with the development of vitreous haemorrhage between the groups [ Time Frame: From baseline to month 6 ]
    Difference in proportion with the development of vitreous haemorrhage between the standard laser treatment group vs. the individualized laser treatment group.

  3. Need for surgical removal of the vitreous between the groups [ Time Frame: From baseline to month 6 ]
    Need for surgical removal of the vitreous between the standard laser treatment group vs. the individualized laser treatment group.

  4. Change in quality of life between the groups [ Time Frame: From baseline to month 6 ]
    Change in quality of life between the standard laser treatment group vs. the individualized laser treatment group.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diabetes mellitus.
  • Newly diagnosed, untreated PDR in one eye (the possibility of inclusion of both eyes by bilateral PDR).

Exclusion Criteria:

  • Diabetic macular edema in the affected eye.
  • Age <18 years.
  • Pregnancy.
  • Ambiguities in refracting media on topical eye.

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): NCT03113006


Contacts
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Contact: Anna S Vergmann, M.D. +45 6541 1682 anna.stage.vergmann@rsyd.dk

Locations
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Denmark
The Department of Ophthalmology, Odense University Hospital Recruiting
Odense, The Region Of Southern Denmarj, Denmark, 5000
Contact: Anna S Vergmann, M.D.    +45 6541 1682    anna.stage.vergmann@rsyd.dk   
Principal Investigator: Anna S Vergmann, M.D.         
Sub-Investigator: Jakob Grauslund, Professor         
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Velux Fonden
Investigators
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Principal Investigator: Anna S Vergmann, M.D. Odense University Hospital

Publications:
Torp TL, Kawasaki R, Wong TY, Peto T, Grauslund J. Improvement in retinal venous oxygen saturation after panretinal photocoagulation is predictive of progression of proliferative diabetic retinopathy. ARVO, 2016;6356-C0143.
Torp TL, Frydkjær-Olsen U, Hansen RS, Peto T, Grauslund J. Intra- and intergrader reliability of semiautomatic measurements of fundus fluorescein angiography leakage in proliferative diabetic retinopathy. European Journal of Ophthalmology, 2015;25(3):e7-e30.

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Responsible Party: Anna Stage Vergmann, Ph. D. student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03113006     History of Changes
Other Study ID Numbers: S-20160168
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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