A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema (GUARDIAN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Retina Institute of Hawaii.
Recruitment status was  Available
Sponsor:
Collaborator:
Eyetech Pharmaceuticals
Information provided by (Responsible Party):
Retina Institute of Hawaii
ClinicalTrials.gov Identifier:
NCT01487044
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

Establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly during the initial treatment period when the VEGF levels are the greatest and then gradually extending the administration frequency to monthly as homeostasis ensues for the treatment of DME, as measured by best-corrected visual acuity.


Condition Intervention
Diabetic Macular Edema
Drug: Macugen (Pegaptanib Sodium)

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

Resource links provided by NLM:


Further study details as provided by Retina Institute of Hawaii:

Intervention Details:
    Drug: Macugen (Pegaptanib Sodium)

    Pegaptanib sodium drug substance is a pegylated (40 kDa branched PEG molecule consisting of two 20 kDa PEG arms) anti-VEGF aptamer. It is formulated in phosphate buffered saline at pH 6-7. Sodium hydroxide or hydrochloric acid may be added for pH adjustment.

    Pegaptanib sodium is formulated at 0.3mg/90µl and presented in USP Type I glass barrel syringes sealed with a bromobutyl rubber plunger stopper. The syringe has a needle attachment at allows for a 30-guage need to be fixed to the syringe prior to injection. The stoppered syringe is packaged in a foil pouch. The drug product is preservative-free and intended for single use by intravitreous injection only.

Detailed Description:

Determine if high frequency loading intravitreal pegaptanib will reduce the area and/or volume of DME, as assessed by Spectral Domain optical coherence tomography (SD-OCT) and to determine if this loading with gradual taper schedule of intravitreal pegaptanib will reduce the need for macular laser treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Type I or Type II diabetics, with an age of 18 years of older
  • Vision of 20/40-20/400 in the Study Eye
  • Diabetic Macular Edema as documented by SD-OCT and Fluorescein Angiogram.

Exclusion Criteria:

  • Cannot attened all trail required visits
  • Eyes in which retinal surgery is needed now are is likely to be needed within 6 months, which the surgeon believes will not respond to non-surgical intervention.
  • Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion greater than 1 disc area involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and/or significant opacification, or presence of chorioretinal atrophy involving the center of the macula.
  • Vitreomacular traction determined clinically and/or by OCT, which, in the investigator's opinion, contributes to the macular edema, or causes associated foveal detachment, and would preclude improvement with pegaptanib sodium.
  • Previous treatment with intravitreal corticosteroids in the study eye within 3 months of Day 0 visit.
  • Previous treatment with intravitreal anti-angiogenic drugs in the study eye within 2 months of Day 0 visit.
  • Previous intraocular surgery within 30 days of Day 0 visit.
  • Any ocular or periocular infection within 30 days of Day 0 visit.
  • Any of the following underlying diseases including:

History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrythmias requiring ongoing treatment.

History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.

History or evidence of clinically significant impaired renal or hepatic function Stroke (within 12 months of trial entry). Any major surgical procedure within one month of trial entry.

  • Any treatment with an investigational agent in the past 30 days for any condition.
  • Known serious allergies to the fluorescein dye used in angiography or to the components of pegaptanib sodium formulation.
  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: NCT01487044

Contacts
Contact: Michael D Bennett, MD (808) 955-0255 mikebennett@retinahawaii.com

Locations
United States, Hawaii
Retina Institute of Hawaii
Honolulu, Hawaii, United States, 96815
Contact: Debbie Shimabukuro, RN    808-955-0255    deb@retinahawaii.com   
Contact: Jenny Song    (808) 955-0255 ext 177    jenny@retinahawaii.com   
Principal Investigator: Michael D Bennett, MD         
Sponsors and Collaborators
Retina Institute of Hawaii
Eyetech Pharmaceuticals
Investigators
Principal Investigator: Michael D Bennett, MD Retina Institute of Hawaii
  More Information

No publications provided

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01487044     History of Changes
Other Study ID Numbers: RIH 1006
Study First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Institute of Hawaii:
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014