NCT02157350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

June 4, 2014

Last Update Submit

January 23, 2019

Conditions

Proliferative Diabetic Retinopathy

Keywords

Eye DiseasesProliferative Diabetic RetinopathyRetinal Vessel GeometryRetinal OxymetryRetina IschemiaPanretinal PhotocoagulationLasers, SemiconductorFluorescein Angiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Retinal vessel geometry (caliber, fractals and tortuosity)

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

Other Outcomes (2)

  • Retinal vessel oxygen saturation

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

  • Retinal areas of non-perfusion.

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

Study Arms (1)

Panretinal Laser Photocoagulation

EXPERIMENTAL

See interventional description.

Procedure: Panretinal laser photocoagulation

Interventions

Panretinal laser photocoagulationPROCEDURE

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.

Also known as: NAVILAS laser, Retinal Laser Photocoagulation
Panretinal Laser Photocoagulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus
  • Proliferative diabetic retinopathy of one or both eyes

You may not qualify if:

  • Diabetic macular edema on current eye
  • Earlier PRP treatment on current eye
  • Cataract demanding treatment on current eye
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Odense, Fyn, 5000, Denmark

Location

Related Publications (18)

  • Grauslund J, Green A, Sjolie 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.

    PMID: 19744716BACKGROUND

  • Grauslund J, Green A, Sjolie 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.

    PMID: 19593541BACKGROUND

  • Stefansson E. Ocular oxygenation and the treatment of diabetic retinopathy. Surv Ophthalmol. 2006 Jul-Aug;51(4):364-80. doi: 10.1016/j.survophthal.2006.04.005.

    PMID: 16818083BACKGROUND

  • Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0.

    PMID: 944535BACKGROUND

  • 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.

    PMID: 7196564BACKGROUND

  • 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. doi: 10.1016/s0161-6420(87)33526-2.

    PMID: 3658347BACKGROUND

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

    PMID: 2062512BACKGROUND

  • 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. doi: 10.1001/archopht.122.1.76.

    PMID: 14718299BACKGROUND

  • 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.

    PMID: 18184895BACKGROUND

  • 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. doi: 10.1016/j.ophtha.2007.02.023. Epub 2007 May 30.

    PMID: 17540447BACKGROUND

  • Grauslund J, Hodgson L, Kawasaki R, Green A, Sjolie 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.

    PMID: 19618163BACKGROUND

  • Grauslund J, Green A, Kawasaki R, Hodgson L, Sjolie 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.

    PMID: 20176399BACKGROUND

  • 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.

    PMID: 21625945BACKGROUND

  • Jorgensen 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.

    PMID: 24330421BACKGROUND

  • 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.

    PMID: 22868445BACKGROUND

  • Kernt M, Cheuteu R, Vounotrypidis E, Haritoglou C, Kampik A, Ulbig MW, Neubauer AS. Focal and panretinal photocoagulation with a navigated laser (NAVILAS(R)). Acta Ophthalmol. 2011 Dec;89(8):e662-4. doi: 10.1111/j.1755-3768.2010.02017.x. Epub 2010 Oct 14. No abstract available.

    PMID: 20946326BACKGROUND

  • Hardarson SH. Retinal oximetry. Acta Ophthalmol. 2013 Aug;91(5):489-90. doi: 10.1111/aos.12239. No abstract available.

    PMID: 23844858BACKGROUND

  • Geirsdottir A, Palsson O, Hardarson SH, Olafsdottir OB, Kristjansdottir JV, Stefansson 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.

    PMID: 22786895BACKGROUND

Related Links

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Thomas L Torp, MD

    Research Unit of Ophthalmology, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Joakob Grauslund, DMSci, PhD

    Research Unit of Ophthalmology, University of Southern Denmark

    STUDY DIRECTOR

  • Tundo Peto, PhD,FHCO

    NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS

    STUDY CHAIR

  • Tien Y Wong, PhD

    Department of Ophthalmology National University of Singapore

    STUDY CHAIR

  • Ryo Kawasaki, PhD

    Department of Public Health Ophthalmology, Yamagata

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Panretinal photocoagulation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

August 1, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)