This trial is active, not recruiting.

Condition diabetic retinopathy
Treatments glatiramer acetate (copaxone), mannitol
Phase phase 4
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
Group which received Copaxone
glatiramer acetate (copaxone) Copaxone (Glatiramer acetate, COP, Copolymer-1)
Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.
(Placebo Comparator)
Group which received Mannitol
Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

Primary Outcomes

Retinal function
time frame: one year

Secondary Outcomes

Nerve fiber layer thickness
time frame: one year

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.