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

• Status: Unknown status
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: (T,G)-A-L; Glatiramer Acetate; Mannitol

Criteria

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