The Individually Marked Panretinal lasEr phoTokoagUlation for Proliferative Diabetic Retinopathy Study - DETECT

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study to Identify Predictive Factors for Progression and Regression of Proliferative Diabetic Retinopathy in Patients Receiving Standard Panretinal Laser Photocoagulation.

Conditions
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Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Procedure: Panretinal laser photocoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Panretinal photocoagulation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panretinal Laser Photocoagulation<br>See interventional description. | Procedure: Panretinal laser photocoagulation<br>* 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.<br>* Other names: Retinal Laser Photocoagulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proliferative diabetic retinopathy progression/regression. | 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). | Change from baseline in proliferative diabetic retinopathy at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vessel geometry (caliber, fractals and tortuosity) | Change in vessel geometry: Caliber: Using a computerised program - SIVA / IVAN. Fractals: Using a computerised program - SIVA. Tortuosity: Using a computerised program - SIVA | Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retina Ischemia, Eye Diseases, Proliferative Diabetic Retinopathy, Retinal Vessel Geometry, Retinal Oxymetry, Panretinal Photocoagulation, Lasers, Semiconductor, Fluorescein Angiography