Status:
WITHDRAWN
Panretinal Photo-stimulation in Proliferative Diabetic Retinopathy
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Severe Non-proliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 Prolifer...
Detailed Description
The published evidence from clinical trials in the literature has demonstrated that conventional PRP using 2000-2500 burns may be used safely and effectively in PDR patients over 2 or 3 sessions. A re...
Eligibility Criteria
Inclusion
- Patient-eligibility
- Inclusion criteria:
- 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
- Inclusion criteria:
- 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
Exclusion
- Patient-eligibility
- Exclusion criteria:
- 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
- Exclusion criteria:
- 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
- Active lid or adnexal infection
- Planned intra-ocular surgery within one year
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02309502
Start Date
October 1 2012
End Date
December 1 2015
Last Update
March 17 2020
Active Locations (1)
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1
Central Manchester Foundation Trust
Manchester, England, United Kingdom, M13 9WL