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

Proliferative Diabetic Retinopathy Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157350
• Other study ID #: OUH-4202-ID-2018
• Secondary ID: S-20140046
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Procedure:
• Panretinal laser photocoagulation
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.

Locations

Country	Name	City	State
Denmark	Research Unit of Ophthalmology, Clinical Institute, University of Southern Denmark, Department of Ophthalmology, Odense University Hospital.	Odense	Fyn

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Moorfields Eye Hospital NHS Foundation Trust, National University, Singapore, University of Southern Denmark, Yamagata University

Country where clinical trial is conducted

Denmark, 

References & Publications (18)

Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85. — View Citation

Ferris FL 3rd, Podgor MJ, Davis MD. Macular edema in Diabetic Retinopathy Study patients. Diabetic Retinopathy Study Report Number 12. Ophthalmology. 1987 Jul;94(7):754-60. — View Citation

Geirsdottir A, Palsson O, Hardarson SH, Olafsdottir OB, Kristjansdottir JV, Stefánsson E. Retinal vessel oxygen saturation in healthy individuals. Invest Ophthalmol Vis Sci. 2012 Aug 13;53(9):5433-42. doi: 10.1167/iovs.12-9912. — View Citation

Grauslund J, Green A, Kawasaki R, Hodgson L, Sjølie AK, Wong TY. Retinal vascular fractals and microvascular and macrovascular complications in type 1 diabetes. Ophthalmology. 2010 Jul;117(7):1400-5. doi: 10.1016/j.ophtha.2009.10.047. Epub 2010 Feb 21. — View Citation

Grauslund J, Green A, Sjølie AK. Blindness in a 25-year follow-up of a population-based cohort of Danish type 1 diabetic patients. Ophthalmology. 2009 Nov;116(11):2170-4. doi: 10.1016/j.ophtha.2009.04.043. Epub 2009 Sep 10. — View Citation

Grauslund J, Green A, Sjølie AK. Prevalence and 25 year incidence of proliferative retinopathy among Danish type 1 diabetic patients. Diabetologia. 2009 Sep;52(9):1829-35. doi: 10.1007/s00125-009-1450-4. Epub 2009 Jul 12. — View Citation

Grauslund J, Hodgson L, Kawasaki R, Green A, Sjølie AK, Wong TY. Retinal vessel calibre and micro- and macrovascular complications in type 1 diabetes. Diabetologia. 2009 Oct;52(10):2213-7. doi: 10.1007/s00125-009-1459-8. Epub 2009 Jul 18. — View Citation

Hardarson SH. Retinal oximetry. Acta Ophthalmol. 2013 Aug;91(5):489-90. doi: 10.1111/aos.12239. — View Citation

Jørgensen CM, Hardarson SH, Bek T. The oxygen saturation in retinal vessels from diabetic patients depends on the severity and type of vision-threatening retinopathy. Acta Ophthalmol. 2014 Feb;92(1):34-9. doi: 10.1111/aos.12283. Epub 2013 Dec 16. — View Citation

Kernt M, Cheuteu R, Vounotrypidis E, Haritoglou C, Kampik A, Ulbig MW, Neubauer AS. Focal and panretinal photocoagulation with a navigated laser (NAVILAS®). Acta Ophthalmol. 2011 Dec;89(8):e662-4. doi: 10.1111/j.1755-3768.2010.02017.x. Epub 2010 Oct 14. — View Citation

Klein R, Klein BE, Moss SE, Wong TY, Hubbard L, Cruickshanks KJ, Palta M. The relation of retinal vessel caliber to the incidence and progression of diabetic retinopathy: XIX: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Ophthalmol. 2004 Jan;122(1):76-83. — View Citation

Klein R, Klein BE, Moss SE, Wong TY. Retinal vessel caliber and microvascular and macrovascular disease in type 2 diabetes: XXI: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Ophthalmology. 2007 Oct;114(10):1884-92. Epub 2007 May 30. — View Citation

Ober MD, Kernt M, Cortes MA, Kozak I. Time required for navigated macular laser photocoagulation treatment with the Navilas. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1049-53. doi: 10.1007/s00417-012-2119-0. Epub 2012 Aug 7. — View Citation

Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600. — View Citation

Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. — View Citation

Rogers SL, Tikellis G, Cheung N, Tapp R, Shaw J, Zimmet PZ, Mitchell P, Wang JJ, Wong TY. Retinal arteriolar caliber predicts incident retinopathy: the Australian Diabetes, Obesity and Lifestyle (AusDiab) study. Diabetes Care. 2008 Apr;31(4):761-3. doi: 10.2337/dc07-1622. Epub 2008 Jan 9. — View Citation

Sasongko MB, Wong TY, Nguyen TT, Cheung CY, Shaw JE, Wang JJ. Retinal vascular tortuosity in persons with diabetes and diabetic retinopathy. Diabetologia. 2011 Sep;54(9):2409-16. doi: 10.1007/s00125-011-2200-y. Epub 2011 May 29. — View Citation

Stefánsson E. Ocular oxygenation and the treatment of diabetic retinopathy. Surv Ophthalmol. 2006 Jul-Aug;51(4):364-80. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Retinal vessel oxygen saturation	Oxymap T1 with the Oxymap Analyser. Non-invasively measuring the vessel saturation of both arterioles and venules in percentage.	Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.
Other	Retinal areas of non-perfusion.	Using wide-field fluorescein angiography	Measurements assessed at baseline and 3 and 6 months after panretinal laser photocoagulation.
Primary	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	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.

External Links

•   Odense University Hospital
•   The Danish Data Protection Agency
•   The Regional Scientific Ethical Committees for Southern Denmark
•   University of Southern denmark