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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00677664

Collaborator

(none)

Enrollment

Location

Arms

26.1

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: Glatiramer acetate (Copaxone) Drug: Mannitol	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Jul 1, 2006

Anticipated Primary Completion Date :

Jul 1, 2008

Anticipated Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Group which received Copaxone	Drug: Glatiramer acetate (Copaxone) Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week. Other Names: Copaxone (Glatiramer acetate, COP, Copolymer-1)
Placebo Comparator: B Group which received Mannitol	Drug: Mannitol Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

Arm

Intervention/Treatment

Active Comparator: A

Group which received Copaxone

Drug: Glatiramer acetate (Copaxone)

Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

Other Names:

Copaxone (Glatiramer acetate, COP, Copolymer-1)

Placebo Comparator: B

Group which received Mannitol

Drug: Mannitol

Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

Outcome Measures

Primary Outcome Measures

Retinal function [one year]

Secondary Outcome Measures

Nerve fiber layer thickness [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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