The Individually Marked Panretinal lasEr phoTokoagUlation for Proliferative Diabetic Retinopathy Study - DETECT
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Panretinal laser photocoagulation
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): NAVILAS laser; Retinal Laser Photocoagulation
Intervention model: Single Group Assignment
Intervention model description: Panretinal photocoagulation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eye Diseases; Proliferative Diabetic Retinopathy; Retinal Vessel Geometry; Retinal Oxymetry; Retina Ischemia; Panretinal Photocoagulation; Lasers, Semiconductor; Fluorescein Angiography