Clinical trial NCT02956759: Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial
Official title: Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
Pan-retinal photocoagulation
proliferative
non-proliferative
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Queen's University, Belfast
First posted: 2016-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: China now has the world's largest number of diabetic persons. Population studies show that only 10% of Chinese rural-dwellers with DR receive therapy. The current standard approach to treatment of DR often requires patients to return for multiple examinations over years, before they reach trial-proven criteria for treatment. This long process is ill-suited to support good compliance with care in low-resource settings. Our recent published review suggests that earlier PRP treatment, which could reduce the burden of compliance, may be clinically effective and cost effective, but the current evidence base is insufficient to make a firm recommendation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of eyes progressing to any degree of PDR
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters
timeFrame: 1 year
measure: Mean change in best corrected visual acuity from baseline to week 52.
timeFrame: 1 year
measure: Proportion of early versus standard treated eyes with: retinal detachment
timeFrame: 1 year
measure: Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography
timeFrame: 1 year
measure: Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists
timeFrame: 1 year
Other outcomes:
measure: Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc)
timeFrame: 1 year
measure: Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire.
timeFrame: 1 year
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Nathan Congdon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wang 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.
citation: Royle 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.
citation: Shimura 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.
citation: Japanese 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.
citation: Fundus 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.