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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Valley Retina Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Victor H. Gonzalez, MD, Valley Retina Institute
ClinicalTrials.gov Identifier:
NCT01486771
First received: December 2, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation.


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Drug: Macugen ® (pegaptanib sodium)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Valley Retina Institute:

Primary Outcome Measures:
  • Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

    To assess the efficacy of intravitreal pegaptanib sodium injections in inducing regression of high risk PDR (as determined by percentage of eyes without treatment failure) using standard panretinal photocoagulation (PRP) as the control arm. Treatment failure is defined as:

    • Development of increased NVD and/or NVE
    • NVD and/or NVE that is not regressed at least 50% compared to the baseline amount within 3 weeks
    • Development of significant vitreous hemorrhage that is sufficient in quantity to obscure visualization of the entire macula, optic disc, and the major temporal arcade vessels


Secondary Outcome Measures:
  • Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    To determine if intravitreal pegaptanib sodium injections maintain or reduce the loss of best-corrected visual acuity as measured by comparing the percentages of patients that lost 3 or more lines on ETDRS chart in the study arms.


Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Macugen Q6
Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals
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.

Experimental: IV Mac Q6 Arm
Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections
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.

Experimental: Pan Retinal Photocoagulation
Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol)
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.


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

  Eligibility

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

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.
  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: NCT01486771

Locations
United States, Texas
Valley Retina Insitute, PA
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Valley Retina Institute
Pfizer
Investigators
Principal Investigator: Victor H. Gonzalez, MD Valley Retina Insitute
  More Information

No publications provided

Responsible Party: Victor H. Gonzalez, MD, Principal Investigator, Valley Retina Institute
ClinicalTrials.gov Identifier: NCT01486771     History of Changes
Other Study ID Numbers: MPDRS-ED
Study First Received: December 2, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Valley Retina Institute:
Proliferative Diabetic Retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014