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

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Panretinal laser photocoagulation

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Eye Diseases, Proliferative Diabetic Retinopathy, Retinal Vessel Geometry, Retinal Oxymetry, Retina Ischemia, Panretinal Photocoagulation, Lasers, Semiconductor, Fluorescein Angiography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Unit of Ophthalmology, Clinical Institute, University of Southern Denmark, Department of Ophthalmology, Odense University Hospital.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Panretinal Laser Photocoagulation

Arm Description

See interventional description.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02157350

First Posted

June 4, 2014

Last Updated

January 23, 2019

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark, Moorfields Eye Hospital NHS Foundation Trust, National University of Singapore, Yamagata University

1. Study Identification

Unique Protocol Identification Number

NCT02157350

Brief Title

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

Acronym

IMPETUS-D

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

September 30, 2017 (Actual)

Study Completion Date

September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark, Moorfields Eye Hospital NHS Foundation Trust, National University of Singapore, Yamagata University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

Keywords

Eye Diseases, Proliferative Diabetic Retinopathy, Retinal Vessel Geometry, Retinal Oxymetry, Retina Ischemia, Panretinal Photocoagulation, Lasers, Semiconductor, Fluorescein Angiography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Panretinal photocoagulation

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panretinal Laser Photocoagulation

Arm Type

Experimental

Arm Description

See interventional description.

Intervention Type

Procedure

Intervention Name(s)

Panretinal laser photocoagulation

Other Intervention Name(s)

NAVILAS laser, Retinal Laser Photocoagulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proliferative diabetic retinopathy progression/regression.

Description

Time Frame

Change from baseline in proliferative diabetic retinopathy at 6 months

Secondary Outcome Measure Information:

Title

Retinal vessel geometry (caliber, fractals and tortuosity)

Description

Change in vessel geometry: Caliber: Using a computerised program - SIVA / IVAN. Fractals: Using a computerised program - SIVA. Tortuosity: Using a computerised program - SIVA

Time Frame

Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.

Other Pre-specified Outcome Measures:

Title

Retinal vessel oxygen saturation

Description

Oxymap T1 with the Oxymap Analyser. Non-invasively measuring the vessel saturation of both arterioles and venules in percentage.

Time Frame

Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.

Title

Retinal areas of non-perfusion.

Description

Using wide-field fluorescein angiography

Time Frame

Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials: