Retinal DetachmentPDRNCT01270542
Avastin for PDR (Proliferative Diabetic Retinopathy)
A study testing Avastin (bevacizumab) in people with Retinal Detachment and Diabetic Retinopathy, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment, Diabetic Retinopathy
- What is being tested?
- Avastin (bevacizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.
Who cannot join
- Dense vitreous hemorrhage
- Inability to follow-up for surgery within 3-7 days after intravitreal injection
- History of stroke, thromboembolic event, or heart attack within the last 6 months
- Less than 18 years of age
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Effect of Pre-operative Adjunctive Anti-VEGF on Growth Factors in Severe Proliferative Diabetic Retinopathy Requiring Surgical Management
The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).
Read the detailed description
Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.
- Conditions
- Retinal Detachment, Diabetic Retinopathy
- Being tested
- Avastin (bevacizumab), Sham injection
- Keywords
- Traction Retinal Detachment (PDR), Proliferative Diabetic Retinopathy (PDR)
- Medical subject headings
- Retinal Detachment, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (bevacizumab)Drug
Also called Avastin
single 0.05 mL intravitreal injection of bevacizumab 1.25 mg
Sham injectionOther
Also called Sham
Subject's eyes will be anesthetized but no injection will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Avastin Injection Group (AIG) | Experimental | Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. Receives: Drug: Avastin (bevacizumab) |
| Sham Injection Group (SIG) | Sham comparator | Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR
Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.
Measured: 3 months after last surgery
Secondary outcomes (2)
Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.
Measured: 3 months after last surgery.
Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.
Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3)
Measured: 3 months from last surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Eliott, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270542
- Sponsor's protocol ID
- USC-HS-09-00068
- Acronym
- PDR
- Status last verified
- May 2014
- First submitted
- 1 Dec 2010
- Last updated
- 17 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dervenis 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 37260074Sohn EH, He S, Kim LA, Salehi-Had H, Javaheri M, Spee C, Dustin L, Hinton DR, Eliott D. Angiofibrotic response to vascular endothelial growth factor inhibition in diabetic retinal detachment: report no. 1. Arch Ophthalmol. 2012 Sep;130(9):1127-34. doi: 10.1001/archophthalmol.2012.1611.
PubMed 22965588
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Adjunctive Anti-VEGF on Growth Factors in Severe Proliferative Diabetic Retinopathy Requiring Surgical Management
- ClinicalTrials.gov ID
- NCT01270542
- Acronym / sponsor ID
- PDR / USC-HS-09-00068
- Conditions
- Retinal Detachment, Diabetic Retinopathy
- Keywords
- Traction Retinal Detachment (PDR), Proliferative Diabetic Retinopathy (PDR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 17 Aug 2017
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 determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).
Detailed description
Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avastin Injection Group (AIG) | Experimental | Drug: Avastin (bevacizumab)Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
| Sham Injection Group (SIG) | Sham comparator | Other: Sham injectionSubjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.
Key exclusion criteria (5 listed)
- Dense vitreous hemorrhage
- Inability to follow-up for surgery within 3-7 days after intravitreal injection
- History of stroke, thromboembolic event, or heart attack within the last 6 months
- Less than 18 years of age
- Pregnancy
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 |
|---|---|---|
| Avastin (bevacizumab)Also: Avastinsingle 0.05 mL intravitreal injection of bevacizumab 1.25 mg | Drug | Avastin Injection Group (AIG) |
| Sham injectionAlso: ShamSubject's eyes will be anesthetized but no injection will be performed. | Other | Sham Injection Group (SIG) |
Primary outcome
The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR
Time frame: 3 months after last surgery
Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.
2 secondary outcomes
Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.
Time frame: 3 months after last surgery.
Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.
Time frame: 3 months from last surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 22965588Sohn EH, He S, Kim LA, Salehi-Had H, Javaheri M, Spee C, Dustin L, Hinton DR, Eliott D. Angiofibrotic response to vascular endothelial growth factor inhibition in diabetic retinal detachment: report no. 1. Arch Ophthalmol. 2012 Sep;130(9):1127-34. doi: 10.1001/archophthalmol.2012.1611.
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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.
Dean Eliott, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avastin (bevacizumab) in people with Retinal Detachment and Diabetic Retinopathy, run by University of Southern California 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 17 Aug 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (time frame: 3 months after last surgery). 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 NCT01270542, which also lists 2 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 17 Aug 2017.