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

NCT01486771 | Unknown Phase 4

• 1 other identifier: MPDRS-ED
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

  54 weeks

Secondary Outcomes (1)

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

  54 weeks

Study Arms (3)

IV Macugen Q6

EXPERIMENTAL

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

Drug: Macugen ® (pegaptanib sodium)

IV Mac Q6 Arm

EXPERIMENTAL

Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections

Drug: Macugen ® (pegaptanib sodium)

Pan Retinal Photocoagulation

EXPERIMENTAL

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

Drug: Macugen ® (pegaptanib sodium)

Interventions

Macugen ® (pegaptanib sodium) DRUG

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.

IV Mac Q6 Arm; IV Macugen Q6; Pan Retinal Photocoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valley Retina Institute: lead
• Pfizer: collaborator

Study Sites (1)

Valley Retina Insitute, PA

McAllen, Texas, 78503, United States

Location

MeSH Terms

Interventions

pegaptanib

Study Officials

• Victor H. Gonzalez, MD

  Valley Retina Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2014
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

US (1)