Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation
This trial is active, not recruiting.
|Treatments||glatiramer acetate (copaxone), mannitol|
|Sponsor||Federal University of São Paulo|
|Start date||July 2006|
|End date||July 2008|
|Trial size||30 participants|
|Trial identifier||NCT00677664, COP 001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
time frame: one year
Nerve fiber layer thickness
time frame: one year
Male or female participants from 18 years up to 70 years old.
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
|Official title||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.|
|Principal investigator||Augusto Paranhos Jr, MD|
|Description||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 "B"which 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.|
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