Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in China. Interview data from some patients and survey data from ophthalmologists in the study hospitals will help determine acceptability of early treatment, and how to overcome barriers to increased use of this option.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedMay 9, 2022
March 1, 2022
7 years
October 12, 2016
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of eyes progressing to any degree of PDR
The diagnosis of PDR will be made by detecting either active new vessels in the optic nerve head or elsewhere in the retina as determined by fundus photography read by a masked investigator or preretinal/vitreous haemorrhage at any time during the 12 month follow-up period.
1 year
Secondary Outcomes (5)
Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters
1 year
Mean change in best corrected visual acuity from baseline to week 52.
1 year
Proportion of early versus standard treated eyes with: retinal detachment
1 year
Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography
1 year
Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists
1 year
Other Outcomes (2)
Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc)
1 year
Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire.
1 year
Study Arms (2)
Early Intervention
EXPERIMENTALpan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.
Standard Care
ACTIVE COMPARATORpan-retinal photocoagulation laser treatment deferred until the onset of any PDR.
Interventions
PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.
Eligibility Criteria
You may qualify if:
- Adults aged \>= 18 years with untreated DR at severe or very severe NPDR stage in either one or both eyes, according to the clinical opinion of the investigator.
- Sufficiently clear ocular media to allow visualization of the retina and retinal photography in either eye.
- Capable of giving informed consent.
You may not qualify if:
- DR at later stage of retinopathy than severe or very severe (eg, two or more of the 4-2-1 criteria are met) NPDR in either eye, but a patient may be enrolled if one eye has severe or very severe NPDR and the fellow eye has PRP-treated PDR and has been stable after treatment.
- Clinically significant macular edema in either eye.
- Dense cataracts or other media opacity preventing visualization of the retina in the eye.
- History of previous surgical or laser treatment for DR or other retinal conditions in a study eye, including history of anti-VEGF or corticosteroid injection or focal laser for DME within 6 months, or any history of scleral buckle, vitrectomy or other retinal detachment repair.
- History of other retinal vascular disorders including CRVO, CRAO, BRVO, BRAO in the study eye.
- Previous cataract or glaucoma surgery is specifically allowed if performed ≥ 6 weeks prior to enrollment.
- Pregnancy.
- Severe renal insufficiency treated with hemodialysis treatment, kidney transplant, pancreatic transplant, and intensive insulin therapy initiated within 4 months.
- Nystagmus, unable to cooperate with laser treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Queen's University, Belfastcollaborator
Study Sites (1)
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000, China
Related Publications (6)
Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
PMID: 24002281BACKGROUNDWang FH, Liang YB, Zhang F, Wang JJ, Wei WB, Tao QS, Sun LP, Friedman DS, Wang NL, Wong TY. Prevalence of diabetic retinopathy in rural China: the Handan Eye Study. Ophthalmology. 2009 Mar;116(3):461-7. doi: 10.1016/j.ophtha.2008.10.003. Epub 2009 Jan 24.
PMID: 19168222BACKGROUNDRoyle P, Mistry H, Auguste P, Shyangdan D, Freeman K, Lois N, Waugh N. Pan-retinal photocoagulation and other forms of laser treatment and drug therapies for non-proliferative diabetic retinopathy: systematic review and economic evaluation. Health Technol Assess. 2015 Jul;19(51):v-xxviii, 1-247. doi: 10.3310/hta19510.
PMID: 26173799BACKGROUNDShimura M, Yasuda K, Nakazawa T, Kano T, Ohta S, Tamai M. Quantifying alterations of macular thickness before and after panretinal photocoagulation in patients with severe diabetic retinopathy and good vision. Ophthalmology. 2003 Dec;110(12):2386-94. doi: 10.1016/j.ophtha.2003.05.008.
PMID: 14644723BACKGROUNDJapanese Society of Ophthalmic Diabetology, Subcommittee on the Study of Diabetic Retinopathy Treatment; Sato Y, Kojimahara N, Kitano S, Kato S, Ando N, Yamaguchi N, Hori S. Multicenter randomized clinical trial of retinal photocoagulation for preproliferative diabetic retinopathy. Jpn J Ophthalmol. 2012 Jan;56(1):52-9. doi: 10.1007/s10384-011-0095-2. Epub 2011 Oct 19.
PMID: 22009219BACKGROUNDFundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33.
PMID: 2062515BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Congdon, PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2016
First Posted
November 7, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
May 9, 2022
Record last verified: 2022-03