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

May 13, 2008 updated by: Federal University of São Paulo

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal function
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Nerve fiber layer thickness
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Augusto Paranhos Jr, MD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ANTICIPATED)

July 1, 2008

Study Completion (ANTICIPATED)

September 1, 2008

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 13, 2008

First Posted (ESTIMATE)

May 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2008

Last Update Submitted That Met QC Criteria

May 13, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COP 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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