Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)

NCT01486771

Last updated date
Study Location
Valley Retina Insitute, PA
McAllen, Texas, 78503, 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.
Proliferative Diabetic Retinopathy
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

1. Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:

- Mild neovascularization of the disc (NVD) of at least 1/4 to 1/3 disc area as shown in standard photograph 10A of the DRS.

- Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS.

2. ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit.

3. Eyes with mild pre-retinal hemorrhage (PRH) or mild vitreous hemorrhage (VH) that does not interfere with clear visualization of the macula and optic disc are eligible for this study.

4. Evaluating physician believes that PRP can be safely withheld for 3 weeks.

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


1. Presence of moderate or dense PRH or VH that prevents clear visualization of the
macula and/or optic disc.


2. Presence of either:


- significant epiretinal membranes involving the macula, OR


- proliferative diabetic membranes along the major retinal arcades that are
extensive enough to cause either:


- significant vitreomacular traction, OR


- significant impairment in visual acuity.


3. Presence of any tractional retinal detachment.


4. Severe ischemia involving the foveal avascular zone as determined by fluorescein
angiography performed at the initial screening visit.


5. Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear
visualization of the macula or optic disc.


6. Presence of neovascular glaucoma with or without hyphema.


7. Previous treatment with intravitreal steroid injections in the study eye within 6
months of baseline.


8. Previous treatment with peribulbar steroid injections in the study eye within 90 days
of baseline


9. Previous PRP laser treatment in the study eye within 90 days of baseline visit.

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Proliferative Diabetic RetinopathyMacugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
NCT01486771
  1. McAllen, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
Official Title  ICMJE A Pilot Study to Determine if Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 12 Weeks for a Year After an Induction Phase of Three Injections Every 6 Weeks Will Reduce the Progression of Proliferative Diabetic Retinopathy in Patients Without Significant Vitreous Hemorrhage in Comparison to Treatment With Retinal Photocoagulation Alone and After an Induction Phase
Brief Summary Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation.
Detailed Description

Primary Objective:

To further establish the efficacy of intravitreal pegaptanib injections in the regression of retinal neovascularization secondary to high-risk PDR, as compared to standard panretinal photocoagulation (PRP)

Secondary Objective:

To maintain the regression of PDR after the induction phase with intravitreal pegaptanib injections administered at 12-week intervals, as compared to standard PRP

To maintain the regression of PDR after the induction phase with retinal photocoagulation applied to areas of ischemia (Selective Laser Photocoagulation), as compared to standard PRP

To evaluate the rate of recurrence of neovascularization after 6 intravitreal pegaptanib injections

To determine if intravitreal pegaptanib will reduce the area and/or volume of concomitant diabetic macular edema, as assessed by leakage on fluorescein angiography (FA) and/or optical coherence tomography (OCT)

To determine if intravitreal pegaptanib injections maintain or reduce the loss of best-corrected visual acuity

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Proliferative Diabetic Retinopathy
Intervention  ICMJE Drug: Macugen ® (pegaptanib sodium)

Patients assigned to either IV Mac Q6Arm will receive a total of 3 intravitreal pegaptanib sodium injections administered at 6-week intervals beginning on Day 0 and ending at Week 12. The group will then receive an intravitreal injection every 12 weeks.

Patients assigned to IV Mac Q6Arm will receive a total of 3 intravitreal pegaptanib sodium injections administered at 6-week intervals beginning on Day 0 and ending at Week 12. After the third injection subjects in this group will receive Selective Laser Photocoagulation at Week 18.

Patients assigned to Panretinal Photocoagulation will act as the control group. Subjects in this group will receive standard Panretinal Photocoagulation using a modified ETDRS protocol.

All intravitreal study injections will consist of 0.3 milligrams (mg) of pegaptanib sodium delivered by intravitreal injection.

Study Arms  ICMJE
  • Experimental: IV Macugen Q6
    Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals
    Intervention: Drug: Macugen ® (pegaptanib sodium)
  • Experimental: IV Mac Q6 Arm
    Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections
    Intervention: Drug: Macugen ® (pegaptanib sodium)
  • Experimental: Pan Retinal Photocoagulation
    Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol)
    Intervention: Drug: Macugen ® (pegaptanib sodium)
Publications * Not Provided

*   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 Unknown status
Actual Enrollment  ICMJE
 (submitted: December 5, 2011)
30
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2014
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:

    • Mild neovascularization of the disc (NVD) of at least 1/4 to 1/3 disc area as shown in standard photograph 10A of the DRS.
    • Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS.
  2. ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit.
  3. Eyes with mild pre-retinal hemorrhage (PRH) or mild vitreous hemorrhage (VH) that does not interfere with clear visualization of the macula and optic disc are eligible for this study.
  4. Evaluating physician believes that PRP can be safely withheld for 3 weeks.

Exclusion Criteria:

  1. Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc.
  2. Presence of either:

    • significant epiretinal membranes involving the macula, OR
    • proliferative diabetic membranes along the major retinal arcades that are extensive enough to cause either:

      • significant vitreomacular traction, OR
      • significant impairment in visual acuity.
  3. Presence of any tractional retinal detachment.
  4. Severe ischemia involving the foveal avascular zone as determined by fluorescein angiography performed at the initial screening visit.
  5. Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc.
  6. Presence of neovascular glaucoma with or without hyphema.
  7. Previous treatment with intravitreal steroid injections in the study eye within 6 months of baseline.
  8. Previous treatment with peribulbar steroid injections in the study eye within 90 days of baseline
  9. Previous PRP laser treatment in the study eye within 90 days of baseline visit.
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 NCT01486771
Other Study ID Numbers  ICMJE MPDRS-ED
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Victor H. Gonzalez, MD, Valley Retina Institute
Study Sponsor  ICMJE Valley Retina Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Victor H. Gonzalez, MDValley Retina Insitute
PRS Account Valley Retina Institute
Verification Date December 2011

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