Proliferative Diabetic RetinopathyPhase 4NCT01486771
Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
A Phase 4 study testing Macugen ® (pegaptanib sodium) in people with Proliferative Diabetic Retinopathy, run by Valley Retina Institute at 1 site in United States.
Trial summary
Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Macugen ® (pegaptanib sodium)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation.
Read the 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
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Macugen ® (pegaptanib sodium)
- Keywords
- Proliferative Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IV Macugen Q6 | Experimental | Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals Receives: Drug: Macugen ® (pegaptanib sodium) |
| IV Mac Q6 Arm | Experimental | Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections Receives: 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) Receives: Drug: Macugen ® (pegaptanib sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 54 weeks
Secondary outcomes (1)
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.
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2007
- Primary completionAug 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Victor H. Gonzalez, MD, Valley Retina Institute
- Investigators
- Victor H. Gonzalez, MD, Principal investigator, Valley Retina Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486771
- Sponsor's protocol ID
- MPDRS-ED
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01486771
- Acronym / sponsor ID
- MPDRS-ED
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative Diabetic Retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Valley Retina InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2007
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV Macugen Q6 | Experimental | Drug: 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 | Experimental | Drug: Macugen ® (pegaptanib sodium)Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections |
| Pan Retinal Photocoagulation | Experimental | Drug: Macugen ® (pegaptanib sodium)Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc.
- Presence of either:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | IV Mac Q6 Arm, IV Macugen Q6, Pan Retinal Photocoagulation |
Primary outcome
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
1 secondary outcome
Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity
Time frame: 54 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor H. Gonzalez, MD principal investigator
Valley Retina Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Macugen ® (pegaptanib sodium) in people with Proliferative Diabetic Retinopathy, run by Valley Retina Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.