NCT00295828

Brief Summary

The purpose of this study is to determine if a drug called Macugen may help to stop the growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of diabetic retinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 4, 2008

Status Verified

September 1, 2008

Enrollment Period

2.7 years

First QC Date

February 22, 2006

Last Update Submit

September 3, 2008

Conditions

Iris NeovascularizationDiabetic Retinopathy

Keywords

VEGFiris neovascularizationdiabetic retinopathyMacugen

Outcome Measures

Primary Outcomes (1)

  • Regression of iris neovascularization and prevention of development of neovascular glaucoma

    prospective

Secondary Outcomes (6)

  • Iris angiogram - conducted at screening/treatment visit,week 1, week 3, week 6, week 9, week 12, week 15, week 18, and week 52.

    prospective

  • Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.

    prospective

  • Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit

    prospective

  • The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.

    prospective

  • A clinically significant reduction in the clock hours of angle neovascularization.

    prospective

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Panretinal Photocoagulation (PRP)

Procedure: Panretinal Photocoagulation (PRP)

2

ACTIVE COMPARATOR

Panretinal Photocoagulation and Macugen Intravitreal Injection

Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation

Interventions

Pegaptanib Sodium Injection/Panretinal PhotocoagulationOTHER

Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.

Also known as: Macugen
2
Panretinal Photocoagulation (PRP)PROCEDURE

Ocular Laser Procedure

Also known as: PRP
1

Eligibility Criteria

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

You may qualify if:

  • Male or female, at least 18 years of age
  • Diabetic retinopathy with iris neovascularization
  • Visual acuity must be light perception or better in the study eye
  • Female patients of childbearing potential must have a negative urine pregnancy test at the screening visit.
  • Written informed consent has been obtained
  • Written authorization for use and release of health and research study information has been obtained

You may not qualify if:

  • Neovascular glaucoma ( a difficult form of glaucoma to control that leads to a painful eye with high intraocular pressure, corneal swelling, and "cell and flare" in the anterior chamber. Caused by abnormal new blood vessel formation (neovascularization) on the iris, that extends over trabecular meshwork causing closure of angle drainage structures).
  • No light perception in the study eye.
  • Inadequate view of retina for PRP/angiography
  • Anterior chamber intraocular lens implant
  • PRP treatment in the past 60 days. Patients may participate if the PRP treatment is beyond 60 days and has newly diagnosed NVI or has nonregression of previously diagnosed NVI.
  • Previous or current Macugen use
  • Any active ocular infection
  • Any conditions which precludes patients ability to comply with study requirements including completion of the study
  • Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
  • Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Robert M Feldman, MD

    Hermann Eye Fund & University of Texas -- Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

January 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 4, 2008

Record last verified: 2008-09

Locations

US(1)