Status:
UNKNOWN
Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation
Lead Sponsor:
Federal University of São Paulo
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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
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 photoc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00677664
Start Date
July 1 2006
End Date
September 1 2008
Last Update
May 14 2008
Active Locations (1)
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1
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04023-900