Panretinal Photo-stimulation in Proliferative Diabetic Retinopathy

NCT02309502 | Withdrawn

• 1 other identifier: R03019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic retinopathy (DR) is a leading cause of new cases of blindness in people aged 20 to 65 years worldwide. Patients with DR may go on to develop a more severe form of the disease called Proliferative Diabetic Retinopathy (PDR), a condition in which abnormal new blood vessels may rupture and bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal photocoagulation (laser treatment) is usually recommended. The purpose of the investigators study is to find if treating patients using a single session of lower intensity laser (Pascal® Pan Retinal Photo-Stimulation, P-RPhS) at an earlier stage in Diabetic Retinopathy (during the severe non-proliferative diabetic retinopathy stage) when the abnormal new vessels are not developed, will prevent diabetic patients to develop PDR. Patients included in the study will be randomized in three arms (randomization). In one arm patients will be treated with the normal parameters used in Pascal® laser, the second arm patients will be treated with a lower intensity than normal, using the Endpoint management system (a new software from the Pascal® laser which allow us to decrees the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the area which has been treated can be viewed. And in the third arm the patients will be observed.

Conditions

Severe Non-proliferative Diabetic Retinopathy

Keywords

diabetic retinopathy; retina; Laser; Pascal

Outcome Measures

Primary Outcomes (1)

• prevention on the developing of proliferative diabetic retinopathy (assessed with slitlamp, color fundus, and fluorangiography)

  assessed with slitlamp, color fundus, and fluorangiography

  12 months

Secondary Outcomes (5)

• regression of Diabetic Retinopathy from Severe Non-Proliferative Stage (S-NPDR) to Moderate Non-Proliferative Stage (M-NPDR) or lesser severity of retinopathy

  12 months

• reduction in visual acuity

  12 months

• reduction in the field of vision

  12 months

• reduction of central retinal thickness

  12 months

• Pain assessment (questionnaire)

  12 months

Study Arms (3)

Green Pascal

EXPERIMENTAL

Single-session Barely Visible Pascal 532nm 3,000 burns 20ms

Device: Green Pascal

Yellow Pascal

EXPERIMENTAL

Single-session P-RPhS; Pascal 577nm 3000 burns 20ms Endpoint Management:70%

Device: Yellow Pascal

Observation

NO INTERVENTION

Observation

Interventions

Green Pascal DEVICE

Single-session Barely Visible Pascal 532nm 3,000 burns 20ms Multi-spot, single session Number of burns: 3,000 Spot size: 400micron Duration: 0.02seconds Exposure: 100% Average power: 100 to 1000 mW Spot spacing: 1 burn-width apart Total number of burns: 3,000 Distribution: From the vascular arcades towards the periphery and in the four quadrants

Green Pascal

Yellow Pascal DEVICE

: Single-session P-RPhS; Pascal 577nm 3000 burns 20ms Endpoint Management: 70% Number of burns: 3,000 Spot size: 400micron Duration: 0.02seconds Exposure: A barely visible burn will be aimed at for the pattern "landmark" burns and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-width apart Total number of burns: 3,000 Distribution: From the vascular arcades towards the periphery and in the four quadrants

Yellow Pascal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient-eligibility
• Older than 18 years of age
• Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
• Able to give informed consent
• Study Eye eligibility
• Treatment-naive S-NPDR
• ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 6/60 or better)
• Any of the following:
• Extensive (\>20) intraretinal hemorrhages in each of 4 quadrants
• Definite venous beading in 2+ quadrants
• Prominent IRMA in 1+ quadrant
• Mean central retinal thickness of less than or equal to 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
• No intra-retinal fluid (IRF) or sub-retinal fluid (SRF) on DRI-OCT
• Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF), DRI-OCT of retina and choroid, Multispectral Imaging (MSI) of chorioretinal oxygenation and P-RPhS
• Ability to perform accurate Humphrey visual field test

You may not qualify if:

• Patient-eligibility
• History of chronic renal failure or renal transplant for diabetic nephropathy
• Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
• Creatinine greater than 1.2 mg/dL
• HDL equal to or greater than 40 mg/dL
• Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg
• Patient is unavailable for follow-up visits
• Pregnant women or breast-feeding females
• Study Eye eligibility
• Lens opacity that could influence vision and results
• Any surgical or non-retinal laser treatment to the study eye within 2 months
• Narrow drainage angles with raised intraocular pressure and angle closure glaucoma.
• Planned YAG peripheral iridotomy
• Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year
• Any previous ocular condition that may be associated with a risk of macular oedema

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Central Manchester Foundation Trust

Manchester, England, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Paulo Stanga

  Manchester Royal Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Paulo Stanga

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: December 5, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

GB (1)