- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621580
Investigating the Structural and Functional Changes to the Retina Following PRP in Diabetic Retinopathy Patients
A 24-Month Cohort Study Assessing the Nature and the Time Course of Structural and Functional Changes to the Retina Following PASCAL Photocoagulation in Proliferative Diabetic Retinopathy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetic retinopathy is the most common cause of adult-acquired retinal vascular disease. Diabetic retinopathy is estimated to affect more than 100 million adults, and is the leading cause of blindness worldwide.
Over the past 30 years, epidemiological studies and clinical trials have shown that early detection through annual eye exams, intensive glucose and blood pressure control, and timely laser photocoagulation could prevent visual loss. More recently, a variety of newer ocular treatments and medications have been introduced, such as the use of the PASCAL photocoagulation laser system, and various anti-vascular endothelial growth factor therapies. While these treatments have revolutionized how diabetic retinopathy patients are managed clinically, questions on appropriate patient selection and the long-term efficacy and safety of these treatments remain to be answered.
The purpose of this study is to focus on studying the nature and the time course over 2 years of structural and functional changes to the retina following PASCAL photocoagulation in severe preproliferative or proliferative diabetic retinopathy patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patient's greater than 18 years of age who have signed an informed consent.
- Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and require PRP surgery in at least one eye.
- Adequate pupil dilation and clear media to perform laser photocoagulation, HRT, OCT and visual field testing.
Exclusion Criteria:
- Advanced lens opacity (Lens opacity that excludes the ability to capture data)
- Prior PRP within the past year
- Focal laser within one year of study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and do not require laser or anti-VEGF treatment in at least one eye.
|
|
Experimental: Treatment: Pan-Retinal Photocoagulation
Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and require PRP laser in at least one eye.
|
Diabetic retinopathy does not usually impair sight until the development of long-term complications, including proliferative retinopathy, a condition in which abnormal new blood vessels may rupture and bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal photocoagulation is usually recommended. During this procedure, a special laser is used to make tiny burns that seal the retina and stop vessels from growing and leaking. Hundreds of tiny spots of laser are placed in the retina to reduce the risk of vitreous haemorrhage and retinal detachment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of structural and functional changes to the retinal thickness following PASCAL PRP in severe PDR patients, assessed by optical coherence tomography.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cindy Hutnik, MD, PhD, Western University
Publications and helpful links
General Publications
- Klein R. Prevention of visual loss from diabetic retinopathy. Surv Ophthalmol. 2002 Dec;47 Suppl 2:S246-52. doi: 10.1016/s0039-6257(02)00388-0.
- Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.
- Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.
- Muqit MM, Marcellino GR, Henson DB, Fenerty CH, Stanga PE. Randomized clinical trial to evaluate the effects of Pascal panretinal photocoagulation on macular nerve fiber layer: Manchester Pascal Study report 3. Retina. 2011 Sep;31(8):1699-707. doi: 10.1097/IAE.0b013e318207d188.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103197
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Retinopathy
-
Retina Institute of HawaiiUnknownDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Severe Nonproliferative Diabetic Retinopathy | Mild Nonproliferative Diabetic Retinopathy | Moderate Nonproliferative Diabetic RetinopathyUnited States
-
University of CataniaUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyItaly
-
Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
-
Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
-
Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
-
Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
-
AEYE Health IncA. Stein Regulatory Affairs Consulting Ltd.RecruitingDiabetic Mellitus | Diabetic Retinopathy, DRUnited States
-
Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
-
King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
-
Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
Clinical Trials on Pan-Retinal Photocoagulation
-
Moorfields Eye Hospital NHS Foundation TrustInsulin Dependant Diabetes TrustCompletedProliferative Diabetic RetinopathyUnited Kingdom
-
Afyon Kocatepe University HospitalCompletedRetinal Degeneration | Diabetic Retinopathy | Macula Abnormality | Laser Burn of Retina
-
United Christian HospitalThe University of Hong KongCompletedDiabetic Retinopathy | Lasers | Treatment Outcome
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Queen's University, BelfastRecruitingDiabetic RetinopathyChina
-
University of MalayaUnknownProliferative Diabetic RetinopathyMalaysia
-
Charles C Wykoff, PhD, MDGenentech, Inc.CompletedCentral Retinal, Hemi Retinal & Brach Retinal Vein OcclusionsUnited States
-
David M. Brown, M.D.Genentech, Inc.CompletedDiabetic Macular EdemaUnited States
-
Wills EyeMid Atlantic RetinaCompletedProliferative Diabetic Retinopathy - High RiskUnited States
-
Cairo UniversityCompletedDiabetic Retinopathy | Proliferative Diabetic Retinopathy | Vascular Endothelial Growth Factor OverexpressionEgypt
-
Odense University HospitalMoorfields Eye Hospital NHS Foundation Trust; University of Southern Denmark; Yamagata University and other collaboratorsCompletedProliferative Diabetic RetinopathyDenmark