Proliferative Diabetic RetinopathyPhase 3No-Crunch01NCT01589718
A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy
A Phase 3 study testing Macugen in people with Proliferative Diabetic Retinopathy, run by Greater Houston Retina Research at 1 site in United States.
Trial summary
The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2014
- Phase
- Phase 3
- 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
- Best corrected visual acuity in the study eye between 20/30 and light perception (LP)
- Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Age ≥ 18 years
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
Who cannot join
- History of anti-VEGF treatment in the study eye
- History of previous pars plana vitrectomy in the study eye
- Intraocular surgery in the study eye within one month of the study
- Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment
- Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
- Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the study period.
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- Active intraocular inflammation (grade trace or above) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment with anti-glaucoma medication)
- History of glaucoma-filtering surgery in the study eye
- History of corneal transplant in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized 1:1, Masked, Study of the Safety, Tolerability, and Efficacy of Intravitreal Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Adjuvant Management of TRD and Vit Hem Associated With PDR
The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.
Read the detailed description
Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection.
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.
Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Macugen, Sham
- Keywords
- Proliferative Diabetic Retinopathy, Tractional Retinal Detachment, Vitreous Hemorrhage
- Medical subject headings
- Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacugenDrug
Also called 0.3mg Pegaptanib Sodium, Macugen
one intravitreal injection of Macugen prior to vitrectomy surgery
ShamDrug
The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.
| Study group | Role | What they receive |
|---|---|---|
| 0.3mg Pegaptanib Sodium, Macugen | Experimental | will receive Macugen intravitreal injection prior to surgery Receives: Drug: Macugen |
| Sham injection | Sham comparator | will receive a sham injection Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tractional Retinal Detachment Repair
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
Measured: 6 months
Secondary outcomes (4)
Post surgical interventions
Post surgical interventions including need for additional surgery, additional injections or PRP laser
Measured: 6 Months
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement
Pre and perioperative fundus photo comparisons on an objective scale
Measured: 6 months
Adverse Events
Incidence and severity of ocular and nonocular adverse events, such as redetachment, progression to neovascular glaucoma, endophthalmitis, etc. through post operative month 3
Measured: 6 months
Visual Acuity
Visual acuity as measured by BCVA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: No patients were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greater Houston Retina Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James C. Major, PhD, MD, Greater Houston Retina Research
- Investigators
- James C Major, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589718
- Sponsor's protocol ID
- No-Crunch 01
- Acronym
- No-Crunch01
- Status last verified
- Mar 2014
- First submitted
- 27 Apr 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez VH, Giuliari GP, Banda RM, Guel DA. Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy. Br J Ophthalmol. 2009 Nov;93(11):1474-8. doi: 10.1136/bjo.2008.155663. Epub 2009 Aug 18.
PubMed 19692371Wroblewski JJ, Wells JA 3rd, Gonzales CR. Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. Am J Ophthalmol. 2010 Jan;149(1):147-54. doi: 10.1016/j.ajo.2009.08.005. Epub 2009 Oct 28.
PubMed 19875087Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.
PubMed 16829817Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.
PubMed 37260074
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized 1:1, Masked, Study of the Safety, Tolerability, and Efficacy of Intravitreal Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Adjuvant Management of TRD and Vit Hem Associated With PDR
- ClinicalTrials.gov ID
- NCT01589718
- Acronym / sponsor ID
- No-Crunch01 / No-Crunch 01
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative Diabetic Retinopathy, Tractional Retinal Detachment, Vitreous Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Greater Houston Retina ResearchUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 May 2012 (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.
The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.
Detailed description
Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection.
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.
Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.3mg Pegaptanib Sodium, Macugen | Experimental | Drug: Macugenwill receive Macugen intravitreal injection prior to surgery |
| Sham injection | Sham comparator | Drug: Shamwill receive a sham injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Best corrected visual acuity in the study eye between 20/30 and light perception (LP)
- Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Age ≥ 18 years
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
Key exclusion criteria (11 listed)
- History of anti-VEGF treatment in the study eye
- History of previous pars plana vitrectomy in the study eye
- Intraocular surgery in the study eye within one month of the study
- Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment
- Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
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 |
|---|---|---|
| MacugenAlso: 0.3mg Pegaptanib Sodium, Macugenone intravitreal injection of Macugen prior to vitrectomy surgery | Drug | 0.3mg Pegaptanib Sodium, Macugen |
| ShamThe subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery. | Drug | Sham injection |
Primary outcome
Tractional Retinal Detachment Repair
Time frame: 6 months
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
4 secondary outcomes
Post surgical interventions
Time frame: 6 Months
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement
Time frame: 6 months
Adverse Events
Time frame: 6 months
Visual Acuity
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Background: PubMed 19692371Gonzalez VH, Giuliari GP, Banda RM, Guel DA. Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy. Br J Ophthalmol. 2009 Nov;93(11):1474-8. doi: 10.1136/bjo.2008.155663. Epub 2009 Aug 18.
- Background: PubMed 19875087Wroblewski JJ, Wells JA 3rd, Gonzales CR. Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. Am J Ophthalmol. 2010 Jan;149(1):147-54. doi: 10.1016/j.ajo.2009.08.005. Epub 2009 Oct 28.
- Background: PubMed 16829817Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.
- Derived from this study: PubMed 37260074Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.
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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.
James C Major, MD principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Macugen in people with Proliferative Diabetic Retinopathy, run by Greater Houston Retina Research 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Mar 2014. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Tractional Retinal Detachment Repair (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589718, which also lists 4 linked publications.
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 5 Mar 2014.