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

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ClinicalTrials.gov Identifier: NCT02956759
Recruitment Status : Unknown
Verified November 2016 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Queen's University, Belfast
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

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.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Procedure: Pan-retinal photocoagulation laser treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Intervention
pan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.
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.
Other Name: PRP laser treatment

Active Comparator: Standard Care
pan-retinal photocoagulation laser treatment deferred until the onset of any PDR.
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.
Other Name: PRP laser treatment




Primary Outcome Measures :
  1. Proportion of eyes progressing to any degree of PDR [ Time Frame: 1 year ]
    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 :
  1. Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters [ Time Frame: 1 year ]
  2. Mean change in best corrected visual acuity from baseline to week 52. [ Time Frame: 1 year ]
  3. Proportion of early versus standard treated eyes with: retinal detachment [ Time Frame: 1 year ]
  4. Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography [ Time Frame: 1 year ]
  5. Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists [ Time Frame: 1 year ]
    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.)


Other Outcome Measures:
  1. 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 ]
  2. Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956759


Contacts
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Contact: Wenhui Zhu, MD 86-20-87755766 ext 8400 dctzwh@139.com

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Nathan Congdon, MD    86-020-87682342    ncongdon1@gmail.com   
Principal Investigator: Nathan Congdon, MD         
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Queen's University, Belfast
Investigators
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Principal Investigator: Nathan Congdon, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications:

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Responsible Party: Congdon Nathan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02956759     History of Changes
Other Study ID Numbers: ZOC-PEARL STUDY
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Congdon Nathan, Sun Yat-sen University:
diabetic retinopathy
Pan-retinal photocoagulation
proliferative
non-proliferative
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases