A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy

PDR Clinical Trial

Official title:

A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487070
• Other study ID #: RIH1005
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2011
• Last updated: December 5, 2011
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2011
• Source: Retina Institute of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary to proliferative diabetic retinopathy.

Secondary objective is to evaluate regression of neovascularization and progression of macular traction utilizing OCT and fundus photographs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy.

Exclusion Criteria:

• Subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• PDR
• Retinal Detachment

Intervention

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 a USP Type I glass barrel syringe sealed with a bromobutyl rubber stopper. A 30-guage needle is fixed to the end of the syringe after removal of the rubber stopper. The syringe comes in a sealed foil pouch, and the 30-gauge needle is added to the sterile injection field separately. The drug product is preservative-free and intended for single use by intravitreous injection only.

Locations

Country	Name	City	State
United States	Retina Institute of Hawaii	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Retina Institute of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.		7-14 days prior to surgical intervention	Yes
Secondary	Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs		7-14 days prior to surgical intervention	No