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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Retina Institute of Hawaii
ClinicalTrials.gov Identifier:
NCT01487070
First received: December 5, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

December 5, 2011
December 5, 2011
April 2011
July 2011   (final data collection date for primary outcome measure)
Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention. [ Time Frame: 7-14 days prior to surgical intervention ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs [ Time Frame: 7-14 days prior to surgical intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
PDR
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.

Experimental: Macugen (Pegaptanib Sodium)
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Intervention: Drug: Macugen (Pegaptanib Sodium)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487070
RIH1005
Not Provided
Retina Institute of Hawaii
Retina Institute of Hawaii
Not Provided
Not Provided
Retina Institute of Hawaii
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP