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

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Macugen ® (pegaptanib sodium)

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc.
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.
Presence of any tractional retinal detachment.
Severe ischemia involving the foveal avascular zone as determined by fluorescein angiography performed at the initial screening visit.
Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc.
Presence of neovascular glaucoma with or without hyphema.
Previous treatment with intravitreal steroid injections in the study eye within 6 months of baseline.
Previous treatment with peribulbar steroid injections in the study eye within 90 days of baseline
Previous PRP laser treatment in the study eye within 90 days of baseline visit.

Sites / Locations

Valley Retina Insitute, PA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

IV Macugen Q6

IV Mac Q6 Arm

Pan Retinal Photocoagulation

Arm Description

Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals

Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections

Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol)

Outcomes

Primary Outcome Measures

Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation

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

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.

Full Information

NCT ID

NCT01486771

First Posted

December 2, 2011

Last Updated

December 5, 2011

Sponsor

Valley Retina Institute

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01486771

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Valley Retina Institute

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV Macugen Q6

Arm Type

Experimental

Arm Description

Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals

Arm Title

IV Mac Q6 Arm

Arm Type

Experimental

Arm Description

Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections

Arm Title

Pan Retinal Photocoagulation

Arm Type

Experimental

Arm Description

Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol)

Intervention Type

Drug

Intervention Name(s)

Macugen ® (pegaptanib sodium)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation

Description

Time Frame

54 weeks

Secondary Outcome Measure Information:

Title

Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity

Description

Time Frame

54 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. 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. Evaluating physician believes that PRP can be safely withheld for 3 weeks. Exclusion Criteria: Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc. 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. Presence of any tractional retinal detachment. Severe ischemia involving the foveal avascular zone as determined by fluorescein angiography performed at the initial screening visit. Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc. Presence of neovascular glaucoma with or without hyphema. Previous treatment with intravitreal steroid injections in the study eye within 6 months of baseline. Previous treatment with peribulbar steroid injections in the study eye within 90 days of baseline Previous PRP laser treatment in the study eye within 90 days of baseline visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor H. Gonzalez, MD

Organizational Affiliation

Valley Retina Insitute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Valley Retina Insitute, PA

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

12. IPD Sharing Statement

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

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