A Pilot Study for the Treatment of Iris Neovascularization With Macugen

This study has been completed.
Sponsor:
Collaborator:
Eyetech Pharmaceuticals
Information provided by:
Hermann Eye Center
ClinicalTrials.gov Identifier:
NCT00295828
First received: February 22, 2006
Last updated: September 3, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Iris Neovascularization
Diabetic Retinopathy
Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation
Procedure: Panretinal Photocoagulation (PRP)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Resource links provided by NLM:


Further study details as provided by Hermann Eye Center:

Primary Outcome Measures:
  • Regression of iris neovascularization and prevention of development of neovascular glaucoma [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Iris angiogram - conducted at screening/treatment visit,week 1, week 3, week 6, week 9, week 12, week 15, week 18, and week 52. [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels. [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization. [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • A clinically significant reduction in the clock hours of angle neovascularization. [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Development of neovascular glaucoma. [ Time Frame: prospective ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Panretinal Photocoagulation (PRP)
Procedure: Panretinal Photocoagulation (PRP)
Ocular Laser Procedure
Other Name: PRP
Active Comparator: 2
Panretinal Photocoagulation and Macugen Intravitreal Injection
Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation
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.
Other Name: Macugen

Detailed Description:

Diabetic retinopathy is an eye condition caused by diabetes in which new blood vessels grow on the retina (the back, inside part of the eye) and the iris. These vessels are not normal and may leak or break, causing bleeding in the eye. This process can lead to vision loss or blindness, glaucoma (disease of the eye where eye pressures are usually too high resulting in damage to the optic nerve), or other eye problems. This study is to determine if a drug called Macugen may help to stop the growth of these abnormal blood vessels on the iris.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

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

Exclusion criteria:

  1. 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).
  2. No light perception in the study eye.
  3. Inadequate view of retina for PRP/angiography
  4. Anterior chamber intraocular lens implant
  5. 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.
  6. Previous or current Macugen use
  7. Any active ocular infection
  8. Any conditions which precludes patients ability to comply with study requirements including completion of the study
  9. Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
  10. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
  11. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295828

Locations
United States, Texas
Robert Cizik Eye Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hermann Eye Center
Eyetech Pharmaceuticals
Investigators
Principal Investigator: Robert M Feldman, MD Hermann Eye Fund & University of Texas -- Houston
  More Information

No publications provided

Responsible Party: Robert M. Feldman, MD, Hermann Eye Center
ClinicalTrials.gov Identifier: NCT00295828     History of Changes
Other Study ID Numbers: HEF-0510
Study First Received: February 22, 2006
Last Updated: September 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Hermann Eye Center:
VEGF
iris neovascularization
diabetic retinopathy
Macugen

Additional relevant MeSH terms:
Diabetic Retinopathy
Neovascularization, Pathologic
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014