A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy

NCT01589718 | Withdrawn Phase 3 DMC

• 1 other identifier: No-Crunch 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy; Tractional Retinal Detachment; Vitreous Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Tractional Retinal Detachment Repair

  Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.

  6 months

Secondary Outcomes (4)

• Post surgical interventions

  6 Months

• Vitreous Hemorrhage and Tractional Retinal Detachment Improvement

  6 months

• Adverse Events

  6 months

• Visual Acuity

  6 months

Study Arms (2)

0.3mg Pegaptanib Sodium, Macugen

EXPERIMENTAL

will receive Macugen intravitreal injection prior to surgery

Drug: Macugen

Sham injection

SHAM COMPARATOR

will receive a sham injection

Drug: Sham

Interventions

Macugen DRUG

one intravitreal injection of Macugen prior to vitrectomy surgery

Also known as: 0.3mg Pegaptanib Sodium, Macugen

0.3mg Pegaptanib Sodium, Macugen

Sham DRUG

The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.

Sham injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Best corrected visual acuity in the study eye between 20/30 and light perception (LP)
• Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
• Age ≥ 18 years
• For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study

You may not qualify if:

• History of anti-VEGF treatment in the study eye
• History of previous pars plana vitrectomy in the study eye
• Intraocular surgery in the study eye within one month of the study
• Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment
• Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
• Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the study period.
• Active intraocular inflammation (grade trace or above) in the study eye
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment with anti-glaucoma medication)
• History of glaucoma-filtering surgery in the study eye
• History of corneal transplant in the study eye

Sponsors & Collaborators

• Greater Houston Retina Research: lead

Study Sites (1)

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (4)

• Gonzalez VH, Giuliari GP, Banda RM, Guel DA. Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy. Br J Ophthalmol. 2009 Nov;93(11):1474-8. doi: 10.1136/bjo.2008.155663. Epub 2009 Aug 18.

  PMID: 19692371 BACKGROUND

• Wroblewski JJ, Wells JA 3rd, Gonzales CR. Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. Am J Ophthalmol. 2010 Jan;149(1):147-54. doi: 10.1016/j.ajo.2009.08.005. Epub 2009 Oct 28.

  PMID: 19875087 BACKGROUND

• Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.

  PMID: 16829817 BACKGROUND

• Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

  PMID: 37260074 DERIVED

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

pegaptanib; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James C Major, MD

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 2, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)