NCT01487044

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.

Trial Health

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Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

First QC Date

December 5, 2011

Last Update Submit

December 5, 2011

Conditions

Diabetic Macular Edema

Keywords

DME

Interventions

Macugen (Pegaptanib Sodium)DRUG

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.

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Institute of Hawaii

Honolulu, Hawaii, 96815, United States

AVAILABLE

MeSH Terms

Interventions

pegaptanib

Study Officials

  • Michael D Bennett, MD

    Retina Institute of Hawaii

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael D Bennett, MD

CONTACT

(808) 955-0255mikebennett@retinahawaii.com

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations

US(1)