NCT00677664

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

2 years

First QC Date

May 12, 2008

Last Update Submit

May 13, 2008

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathypanretinal photocoagulationcopaxonenerve fiber layer thicknessretinal function

Outcome Measures

Primary Outcomes (1)

  • Retinal function

    one year

Secondary Outcomes (1)

  • Nerve fiber layer thickness

    one year

Study Arms (2)

A

ACTIVE COMPARATOR

Group which received Copaxone

Drug: Glatiramer acetate (Copaxone)

B

PLACEBO COMPARATOR

Group which received Mannitol

Drug: Mannitol

Interventions

Glatiramer acetate (Copaxone)DRUG

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

Also known as: Copaxone (Glatiramer acetate, COP, Copolymer-1)
A
MannitolDRUG

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

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 4039601BACKGROUND

  • 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.

    PMID: 8566826BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Glatiramer AcetateCoat Protein Complex IMannitol

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVesicular Transport ProteinsMembrane ProteinsProteinsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Augusto Paranhos Jr, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

July 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

BR(1)