2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`Try the modernized ClinicalTrials.gov beta website. Learn more about the
`modernization effort.
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-
`PDRS ED)
`
`The safety and scientific validity of this study is the responsibility of the study sponsor
`and investigators. Listing a study does not mean it has been evaluated by the U.S.
`Federal Government. Read our disclaimer for details.
`
`
`ClinicalTrials.gov Identifier: NCT01486771
`
`Recruitment Status  : Unknown
`Verified December 2011 by Victor H. Gonzalez, MD, Valley Retina Institute.
`Recruitment status was: Active, not recruiting
`First Posted  : December 6, 2011
`Last Update Posted  : December 6, 2011
`
`Sponsor:
`Valley Retina Institute
`
`Collaborator:
`Pfizer
`
`Information provided by (Responsible Party):
`Victor H. Gonzalez, MD, Valley Retina Institute
`
`Study Details
`
`Tabular View
`
`No Results Posted
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`1/10
`
`Exhibit 2109
`Page 01 of 10
`
`

`

`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`2/4/22, 5:44 PM
`Brief Summary:
`Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce
`the need for retinal photocoagulation.
`
`Condition or disease 
`
`Intervention/treatment 
`
`Phase 
`
`Proliferative Diabetic Retinopathy
`
`Drug: Macugen ® (pegaptanib sodium)
`
`Phase 4
`
`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
`
`Go to
`
`Study Design
`
`Study Type  :
`Interventional (Clinical Trial)
`Actual Enrollment  :
`30 participants
`Allocation:
`Randomized
`Intervention Model:
`Factorial Assignment
`Masking:
`None (Open Label)
`Primary Purpose:
`Treatment
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`2/10
`
`Exhibit 2109
`Page 02 of 10
`
`

`

`2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`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 Start Date  :
`November 2007
`Estimated Primary Completion Date  :
`August 2013
`Estimated Study Completion Date  :
`February 2014
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders
`
`Drug Information available for: Pegaptanib sodium
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm 
`
`Intervention/treatment 
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`3/10
`
`Exhibit 2109
`Page 03 of 10
`
`

`

`2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`Arm 
`
`Intervention/treatment 
`
`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.
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`4/10
`
`Exhibit 2109
`Page 04 of 10
`
`

`

`2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`Arm 
`
`Intervention/treatment 
`
`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.
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`5/10
`
`Exhibit 2109
`Page 05 of 10
`
`

`

`2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`Arm 
`
`Intervention/treatment 
`
`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.
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures  :
`1. 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 ]
`
`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
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`6/10
`
`Exhibit 2109
`Page 06 of 10
`
`

`

`2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`Secondary Outcome Measures  :
`1. Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected
`visual acuity [ Time Frame: 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.
`
`Eligibility Criteria
`
`Go to
`
`Information from the National Library of Medicine
`
`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, Learn About
`Clinical Studies.
`
`Ages Eligible for Study:
`18 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`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.
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`7/10
`
`Exhibit 2109
`Page 07 of 10
`
`

`

`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`2/4/22, 5:44 PM
`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
`
`Go to
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study research staff using the contact
`information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486771
`
`Locations
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`8/10
`
`Exhibit 2109
`Page 08 of 10
`
`

`

`2/4/22, 5:44 PM
`
`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`
`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
`
`Go to
`
`Responsible Party:
`Victor H. Gonzalez, MD, Principal Investigator, Valley Retina Institute
`ClinicalTrials.gov Identifier:
`NCT01486771 History of Changes
`Other Study ID Numbers:
`MPDRS-ED
`First Posted:
`December 6, 2011 Key Record Dates
`Last Update Posted:
`December 6, 2011
`Last Verified:
`December 2011
`
`Keywords provided by Victor H. Gonzalez, MD, Valley Retina Institute:
`Proliferative Diabetic Retinopathy
`
`Additional relevant MeSH terms:
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`9/10
`
`Exhibit 2109
`Page 09 of 10
`
`

`

`Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED) - Full Text View - ClinicalTrials.gov
`2/4/22, 5:44 PM
`Retinal Diseases
`Diabetic Retinopathy
`Eye Diseases
`Diabetic Angiopathies
`Vascular Diseases
`Cardiovascular Diseases
`Diabetes Complications
`Diabetes Mellitus
`Endocrine System Diseases
`
`https://clinicaltrials.gov/ct2/show/NCT01486771
`
`10/10
`
`Exhibit 2109
`Page 10 of 10
`
`