Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of Copaxone injections in retinal function and integrity in diabetic patients who underwent pan-retinal photocoagulation.

Detailed Description
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Purpose: to evaluate the neuroprotective effect of Copaxone (Glatiramer acetate) injections in the nerve fiber layer thickness and retinal function in diabetic patients who underwent panretinal photocoagulation (PRP). Study Design: Double- Masked Randomized Clinical Trial. The follow up period estimated is 12 months after the last PRP section. Patients enrollment: Thirty patients with severe nonproliferative or early proliferative diabetic retinopathy and no previous laser treatment were enrolled. They were divided into two groups: A which received Copaxone or Bwhich received mannitol (placebo) using a block randomization. Both drugs were offered by subcutaneous administration one week prior and in the three sections of PRP, one per week. All patients received and signed a written inform consent approved by the research ethics committee of UNIFESP. Chronogram: All patients received a full ophthalmic examination (best-corrected Log-Mar visual acuity, slit lamp examination, applanation tonometry, fundus biomicroscopy and indirect fundus examination); functional examination (Humphrey 24-2 SITA STANDARD visual field, Electroretingrams and FDT C-20 strategy visual field) and anatomic examination (Color digital photography and fluorescein angiography (FAG), GDX- VCC, Optical Coherence Tomography (OCT) and Heidelberg Retinal Tomography (HRT) before PRP and 1st,3rd,6th months and 1 year after laser, or whenever needed for clinical reasons.

Official Title
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Effects of Glatiramer Acetate (Copaxone) in the Nerve Fiber Layer Thickness and Retinal Function in Diabetic Patients After Pan- Retinal Photocoagulation (PRP), a Double- Masked Randomized Clinical Trial.

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Glatiramer acetate (Copaxone)
* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: Males or females; Females must be post-menopausal for 6 months and must have a negative pregnancy test (serum β-HCG) prior to study entry Age: 18 to 70 years old Type 1 or 2 diabetes, assigned for pan-retinal photocoagulation Vision acuity 20/100 or better SE of ±6,00 DE Volunteer must be willing and able to sign an informed consent Volunteer must be ambulatory and not requiring skilled nursing care Normal skin appearance in areas to be injected (no tattoo, scars, birth marks etc.) Exclusion Criteria: Eye Related: Dense cataract or vitreous opacity Other retinal disease but diabetic retinopathy Glaucoma (IOP higher than 21 mmHg and or Cup disk ratio equal higher than 0.8) or other optic nerve diseases Other eye threatening systemic diseases No ocular surgery in the last 6 months including laser treatment No previous retinal photocoagulation or cryopexy of any kind Systemic exclusion criteria: Known immunological condition/disease No active infection within 30 days prior to enrollment (e.g. urinary tract infection, upper/lower respiratory tract infection, skin infection, arthritis etc.) Use of interferons, immunosuppressive therapy, cytotoxic, corticosteroids, chemotherapy or lymphoid irradiation within 1 year prior to study entry. Serious disease in the past or an unstable disease such as cancer, pulmonary, hepatic, renal, cardiovascular or metabolic diseases History of alcoholism or drug addiction within the past year Volunteer has participated in another clinical trial within the past 90 days or took an experimental drug within time scale of 5 x t1/2 of the experimental drug Unstable psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Group which received Copaxone | Drug: Glatiramer acetate (Copaxone)<br>* Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.<br>* Other names: Copaxone (Glatiramer acetate, COP, Copolymer-1);|
| Placebo Comparator: B<br>Group which received Mannitol | Drug: Mannitol<br>* Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal function |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve fiber layer thickness |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, panretinal photocoagulation, copaxone, nerve fiber layer thickness, retinal function