Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion

NCT00406107 | Completed Phase 4 Results DMC

• 2 other identifiers: PRC-001Pfizer Reference # 20050548
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.

Conditions

Branch Retinal Vein Occlusion

Keywords

branch retinal vein occlusion; macular edema; pegaptanib sodium; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks

  54 Weeks

Secondary Outcomes (4)

• Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield

  54 Weeks

• Safety Parameters

  54 Weeks

• Change in Central Subfield Thickness on OCT From Baseline to Week 54

  54 Weeks

• Change in Macular Volume on OCT From Baseline to Week 54

  54 Weeks

Study Arms (2)

Pegaptanib Sodium 0.3mg (Macugen)

ACTIVE COMPARATOR

Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

Drug: pegaptanib sodium (Macugen)

Pegaptanib Sodium 1 mg (Macugen)

ACTIVE COMPARATOR

Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

Drug: pegaptanib sodium (Macugen)

Interventions

pegaptanib sodium (Macugen) DRUG

Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48.

Also known as: Macugen

Pegaptanib Sodium 0.3mg (Macugen); Pegaptanib Sodium 1 mg (Macugen)

Eligibility Criteria

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

You may qualify if:

• Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age
• Duration of BRVO macular edema less than 6 months prior to baseline visit
• Best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method.
• Central foveal thickness greater than or equal to 250 microns using the OCT-3
• Less than 25% of foveal capillary ring disruption
• Less than 2 disc areas of capillary non-perfusion within 1000 microns of the foveal center
• Absence of hemorrhage or lipid in the foveal center
• Investigator comfortable deferring macular laser for 18 weeks from baseline and intravitreous steroid for 36 weeks from baseline

You may not qualify if:

• Ocular conditions other than BRVO related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor.
• Intraocular surgery within past 3 months
• Significant enlargement of foveal avascular zone(\>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 microns of foveal center.
• Likelihood of evidence driven indication for peripheral photocoagulation in the next 6 months.
• Patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of \>15 letters of vision or thinning of the Center Point on OCT of \>20% from baseline determination
• Prior grid laser within 4 months of baseline or more than one prior grid laser treatment.
• No prior intravitreous or periocular steroid injections in the study eye.

Sponsors & Collaborators

• Palmetto Retina Center, LLC: lead
• Pfizer: collaborator
• Eyetech Pharmaceuticals: collaborator

Study Sites (3)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Cumberland Valley Retina Center

Hagerstown, Maryland, 21740, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Related Publications (6)

• Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.

  PMID: 2866759 BACKGROUND

• Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol. 1984 Sep 15;98(3):271-82. doi: 10.1016/0002-9394(84)90316-7.

  PMID: 6383055 BACKGROUND

• Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33. doi: 10.1016/s0161-6420(95)30849-4.

  PMID: 9097788 BACKGROUND

• Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, Goldbaum M, Guyer DR, Katz B, Patel M, Schwartz SD; Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57. doi: 10.1016/j.ophtha.2005.06.007.

  PMID: 16154196 BACKGROUND

• Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.

  PMID: 7526212 BACKGROUND

• Funatsu H, Yamashita H, Ikeda T, Nakanishi Y, Kitano S, Hori S. Angiotensin II and vascular endothelial growth factor in the vitreous fluid of patients with diabetic macular edema and other retinal disorders. Am J Ophthalmol. 2002 Apr;133(4):537-43. doi: 10.1016/s0002-9394(02)01323-5.

  PMID: 11931788 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Results Point of Contact

• Title: John A. Wells, III, M.D.
• Organization: Palmetto Retina Center

jackwells@palmettoretina.com

803-931-0077

Study Officials

• John A Wells, III, MD

  Palmetto Retina Center, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: December 4, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

US (3)