Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial

Diabetic Retinopathy Clinical Trial

Official title:

Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02956759
• Other study ID #: ZOC-PEARL STUDY
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: Sun Yat-sen University
• Contact: Wenhui Zhu, MD
• Phone: 86-20-87755766
• Email: dctzwh[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Eye Diseases
• Retinal Diseases

Intervention

Procedure:
• Pan-retinal photocoagulation laser treatment
PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University, Queen's University, Belfast

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc)		1 year
Other	Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire.		1 year
Primary	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	Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters		1 year
Secondary	Mean change in best corrected visual acuity from baseline to week 52.		1 year
Secondary	Proportion of early versus standard treated eyes with: retinal detachment		1 year
Secondary	Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography		1 year
Secondary	Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists	Study ophthalmologists will also ascertain the primary outcome measure (diagnosis of any degree of PDR) on the basis of slit-lamp biomicropscopy fundus examination with a contact lens and indirect ophthalmoscopy. We will compare the sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists with the gold stander (diagnosis provided by graders according to the fundus photos.)	1 year