Overview

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