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

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ClinicalTrials.gov Identifier: NCT01487044
Recruitment Status : Available
First Posted : December 7, 2011
Last Update Posted : December 7, 2011
Eyetech Pharmaceuticals
Information provided by (Responsible Party):
Retina Institute of Hawaii

Brief Summary:
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 or disease Intervention/treatment
Diabetic Macular Edema Drug: Macugen (Pegaptanib Sodium)

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.

Study Type : 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 the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487044

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

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
Principal Investigator: Michael D Bennett, MD Retina Institute of Hawaii

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01487044     History of Changes
Other Study ID Numbers: RIH 1006
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 7, 2011
Last Verified: December 2011

Keywords provided by Retina Institute of Hawaii:

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases