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

NCT ID: NCT00677664

Last Updated: 2008-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy; panretinal photocoagulation; copaxone; nerve fiber layer thickness; retinal function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group which received Copaxone

Group Type: ACTIVE_COMPARATOR

Glatiramer acetate (Copaxone)

Intervention Type: DRUG

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

B

Group which received Mannitol

Group Type: PLACEBO_COMPARATOR

Mannitol

Intervention Type: DRUG

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

Interventions

Glatiramer acetate (Copaxone)

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

Intervention Type: DRUG

Mannitol

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

Intervention Type: DRUG

Other Intervention Names

Copaxone (Glatiramer acetate, COP, Copolymer-1)

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of Sao Paulo

Principal Investigators

Augusto Paranhos Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Perlman I, Gdal-On M, Miller B, Zonis S. Retinal function of the diabetic retina after argon laser photocoagulation assessed electroretinographically. Br J Ophthalmol. 1985 Apr;69(4):240-6. doi: 10.1136/bjo.69.4.240.

Reference Type: BACKGROUND

PMID: 4039601 (View on PubMed)

Stitt AW, Gardiner TA, Archer DB. Retinal and choroidal responses to panretinal photocoagulation: an ultrastructural perspective. Graefes Arch Clin Exp Ophthalmol. 1995 Nov;233(11):699-705. doi: 10.1007/BF00164672.

Reference Type: BACKGROUND

PMID: 8566826 (View on PubMed)

Other Identifiers

COP 001

Identifier Type: -

Identifier Source: org_study_id