Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation
- Registration Number
- NCT00677664
- Lead Sponsor
- Federal University of São Paulo
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Glatiramer acetate (Copaxone) Group which received Copaxone B Mannitol Group which received Mannitol
- Primary Outcome Measures
Name Time Method Retinal function one year
- Secondary Outcome Measures
Name Time Method Nerve fiber layer thickness one year
Trial Locations
- Locations (1)
Federal University of Sao Paulo
🇧🇷Sao Paulo, SP, Brazil