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

Phase 4

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Drug: Macugen ® (pegaptanib sodium)

• Registration Number: NCT01486771
• Lead Sponsor: Valley Retina Institute

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 Timeline

• Study Start: 2007-11
• Status Verified: 2011-12
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Last Update Submitted: 2011-12-05
• Study First Posted: 2011-12-06
• Last Update Posted: 2011-12-06
• Primary Completion: 2013-08
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IV Macugen Q6	Macugen ® (pegaptanib sodium)	Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals
IV Mac Q6 Arm	Macugen ® (pegaptanib sodium)	Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections
Pan Retinal Photocoagulation	Macugen ® (pegaptanib sodium)	Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol)

Primary Outcome Measures

Name	Time	Method
Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation	54 weeks	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

Name	Time	Method
Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity	54 weeks	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.

Trial Locations

Locations (1)

Valley Retina Insitute, PA; 🇺🇸 McAllen, Texas, United States