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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Eyetech Pharmaceuticals
Information provided by (Responsible Party):
John A. Wells, III, M.D., Palmetto Retina Center, LLC
ClinicalTrials.gov Identifier:
NCT00406107
First received: November 30, 2006
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Branch Retinal Vein Occlusion
Drug: pegaptanib sodium (Macugen)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Macugen for the Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Palmetto Retina Center, LLC:

Primary Outcome Measures:
  • Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks [ Time Frame: 54 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield [ Time Frame: 54 Weeks ] [ Designated as safety issue: No ]
  • Safety Parameters [ Time Frame: 54 Weeks ] [ Designated as safety issue: Yes ]
    Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.

  • Change in Central Subfield Thickness on OCT From Baseline to Week 54 [ Time Frame: 54 Weeks ] [ Designated as safety issue: No ]
  • Change in Macular Volume on OCT From Baseline to Week 54 [ Time Frame: 54 Weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pegaptanib Sodium 0.3mg (Macugen)
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)
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.
Other Name: Macugen
Active Comparator: Pegaptanib Sodium 1 mg (Macugen)
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)
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.
Other Name: Macugen

Detailed Description:

Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to retinal disease. The main cause of vision loss in all of these disorders is the development of macular edema. Current clinical practice based on randomized controlled clinical trials (ETDRS, BVOS) employs laser photocoagulation, either in a focal or grid pattern, to treat macular edema associated with diabetic retinopathy and branch retinal vein occlusion. Unfortunately, laser photocoagulation is ineffective in central retinal vein occlusion (CRVO), and no proven therapy exists for CRVO.

The pathogenesis of macular edema in retinal vascular diseases is generally accepted to be increased levels of vascular endothelial growth factor (VEGF) due to ischemic or other stimuli. VEGF is known to be one of the most potent stimulators of vascular leakage in humans. Therefore, it seems sensible to study inhibition of VEGF to reduce vascular leakage, reduce macular edema, and improve vision in these retinal vascular disorders.

Phase 2 randomized, controlled clinical trials of Macugen in diabetic macular edema and in macular edema associated with CRVO have been conducted. In the diabetes trial, patients treated with Macugen had improved vision, reduced macular edema as measured by optical coherence tomography (OCT), and reduced need for laser treatment compared to patients treated with sham injections. In the CRVO trial, patients treated with Macugen 1 mg every 6 weeks for 24 weeks had improved vision and reduced macular edema at week 30 compared to sham. This is the first randomized trial of treatment for CRVO to show a benefit over control. Based on these positive findings, we plan to study Macugen treatment of macular edema due to BRVO.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406107

Locations
United States, California
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
United States, Maryland
Cumberland Valley Retina Center
Hagerstown, Maryland, United States, 21740
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
Palmetto Retina Center, LLC
Pfizer
Eyetech Pharmaceuticals
Investigators
Principal Investigator: John A Wells, III, MD Palmetto Retina Center, LLC
  More Information

Publications:
Responsible Party: John A. Wells, III, M.D., Principal Investigator, Palmetto Retina Center, LLC
ClinicalTrials.gov Identifier: NCT00406107     History of Changes
Other Study ID Numbers: PRC-001, Pfizer Reference # 20050548
Study First Received: November 30, 2006
Results First Received: January 30, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Palmetto Retina Center, LLC:
branch retinal vein occlusion
macular edema
pegaptanib sodium
vascular endothelial growth factor

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on October 21, 2014