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

Primary Purpose

Diabetic Retinopathy

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pan-retinal photocoagulation laser treatment

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, Pan-retinal photocoagulation, proliferative, non-proliferative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongshan Ophthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Intervention

Standard Care

Arm Description

pan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.

pan-retinal photocoagulation laser treatment deferred until the onset of any PDR.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters

Mean change in best corrected visual acuity from baseline to week 52.

Proportion of early versus standard treated eyes with: retinal detachment

Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography

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.)

Full Information

NCT ID

NCT02956759

First Posted

October 12, 2016

Last Updated

May 6, 2022

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Queen's University, Belfast

1. Study Identification

Unique Protocol Identification Number

NCT02956759

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 2016 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Queen's University, Belfast

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

diabetic retinopathy, Pan-retinal photocoagulation, proliferative, non-proliferative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early Intervention

Arm Type

Experimental

Arm Description

pan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.

Arm Title

Standard Care

Arm Type

Active Comparator

Arm Description

pan-retinal photocoagulation laser treatment deferred until the onset of any PDR.

Intervention Type

Procedure

Intervention Name(s)

Pan-retinal photocoagulation laser treatment

Other Intervention Name(s)

PRP laser treatment

Intervention Description

PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.

Primary Outcome Measure Information:

Title

Proportion of eyes progressing to any degree of PDR

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters

Time Frame

1 year

Title

Mean change in best corrected visual acuity from baseline to week 52.

Time Frame

1 year

Title

Proportion of early versus standard treated eyes with: retinal detachment

Time Frame

1 year

Title

Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography

Time Frame

1 year

Title

Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists

Description

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc)

Time Frame

1 year

Title

Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenhui Zhu, MD

Phone

86-20-87755766

Ext

8400

dctzwh@139.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathan Congdon, PhD

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Ophthalmic Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathan Congdon, MD

Phone

86-020-87682342

ncongdon1@gmail.com

First Name & Middle Initial & Last Name & Degree

Nathan Congdon, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24002281

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.

Results Reference

background

PubMed Identifier

19168222

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.

Results Reference

background

PubMed Identifier

26173799

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.

Results Reference

background

PubMed Identifier

14644723

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.

Results Reference

background

PubMed Identifier

22009219

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.

Results Reference

background

PubMed Identifier

2062515

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.

Results Reference

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

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