Clinical trial NCT02157350: The Individually Marked Panretinal lasEr phoTokoagUlation for Proliferative Diabetic Retinopathy Study - DETECT
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proliferative Diabetic Retinopathy
Keywords: Eye Diseases
Proliferative Diabetic Retinopathy
Retinal Vessel Geometry
Retinal Oxymetry
Retina Ischemia
Panretinal Photocoagulation
Lasers, Semiconductor
Fluorescein Angiography
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Moorfields Eye Hospital NHS Foundation Trust
name: National University of Singapore
name: Yamagata University
First posted: 2014-06-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Panretinal photocoagulation
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Proliferative diabetic retinopathy progression/regression.
timeFrame: Change from baseline in proliferative diabetic retinopathy at 6 months
Secondary outcomes:
measure: Retinal vessel geometry (caliber, fractals and tortuosity)
timeFrame: Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.
Other outcomes:
measure: Retinal vessel oxygen saturation
timeFrame: Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.
measure: Retinal areas of non-perfusion.
timeFrame: Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.
Locations:
city: Odense
country: Denmark
facility: Research Unit of Ophthalmology, Clinical Institute, University of Southern Denmark, Department of Ophthalmology, Odense University Hospital.
state: Fyn
Study officials:
affiliation: Research Unit of Ophthalmology, University of Southern Denmark
name: Thomas L Torp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit of Ophthalmology, University of Southern Denmark
name: Joakob Grauslund, DMSci, PhD
role: STUDY_DIRECTOR
affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS
name: Tundo Peto, PhD,FHCO
role: STUDY_CHAIR
affiliation: Department of Ophthalmology National University of Singapore
name: Tien Y Wong, PhD
role: STUDY_CHAIR
affiliation: Department of Public Health Ophthalmology, Yamagata
name: Ryo Kawasaki, PhD
role: STUDY_CHAIR
References:
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