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

NCT00406107

Last updated date
Study Location
Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Branch Retinal Vein Occlusion
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Branch Retinal Vein OcclusionEvaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
NCT00406107
  1. Los Angeles, California
  2. Hagerstown, Maryland
  3. West Columbia, South Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Official Title  ICMJE Open Label Macugen for the Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Branch Retinal Vein Occlusion
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: pegaptanib sodium (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.
    Intervention: Drug: pegaptanib sodium (Macugen)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)
20
Original Enrollment  ICMJE
 (submitted: December 1, 2006)
30
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00406107
Other Study ID Numbers  ICMJE PRC-001
Pfizer Reference # 20050548
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John A. Wells, III, M.D., Palmetto Retina Center, LLC
Study Sponsor  ICMJE Palmetto Retina Center, LLC
Collaborators  ICMJE
  • Pfizer
  • Eyetech Pharmaceuticals
Investigators  ICMJE
Principal Investigator:John A Wells, III, MDPalmetto Retina Center, LLC
PRS Account Palmetto Retina Center, LLC
Verification Date September 2014

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