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- Ensaio Clínico NCT02956759
Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial
Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Wenhui Zhu, MD
- Número de telefone: 8400 86-20-87755766
- E-mail: dctzwh@139.com
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Recrutamento
- Zhongshan Ophthalmic Center
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Contato:
- Nathan Congdon, MD
- Número de telefone: 86-020-87682342
- E-mail: ncongdon1@gmail.com
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Investigador principal:
- Nathan Congdon, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Early Intervention
pan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.
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PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.
Outros nomes:
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Comparador Ativo: Standard Care
pan-retinal photocoagulation laser treatment deferred until the onset of any PDR.
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PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Proportion of eyes progressing to any degree of PDR
Prazo: 1 year
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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.
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1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters
Prazo: 1 year
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1 year
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Mean change in best corrected visual acuity from baseline to week 52.
Prazo: 1 year
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1 year
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Proportion of early versus standard treated eyes with: retinal detachment
Prazo: 1 year
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1 year
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Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography
Prazo: 1 year
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1 year
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Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists
Prazo: 1 year
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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.)
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1 year
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Outras medidas de resultado
Medida de resultado |
Prazo |
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Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc)
Prazo: 1 year
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1 year
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Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire.
Prazo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nathan Congdon, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ZOC-PEARL STUDY
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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