Intravitreal Bevacizumab InjectionPhase 1NCT00548197
Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
A Phase 1 study testing Bevacizumab in people with Intravitreal Bevacizumab Injection and Pars Plana Vitrectomy, run by Iran University of Medical Sciences at 1 site in Iran.
Trial summary
Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Feb 2007to Mar 2008
- Phase
- Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.
- Complexity score between 4 and 8.
Who cannot join
- Previous vitreoretinal surgery.
- Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.
Trial locations and contacts
1 site in 1 country.
About this study
Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.
Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..
Read more
In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.
During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.
Read the detailed description
Eligibility criteria:
Diabetic tractional retinal detachment-complexity score between 4 and 8
Main outcome measures:
best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)
- Conditions
- Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment, Diabetic Retinopathy
- Being tested
- Bevacizumab
- Keywords
- Intravitreal Bevacizumab injection, Pars plana vitrectomy, tractional retinal detachment, Diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Brand name of Bevacizumab is Avastin
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Receives: Drug: Bevacizumab |
| Control group | No intervention | no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
Measured: last follow up, an average of 7 months post-operation
Secondary outcomes (1)
Anatomic Status of the Retina
Number of Participants with Postoperative Vitreous Hemorrhage
Measured: Last follow up, an average of 7 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionMar 2008
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 (3)Papers the sponsor has linked to this study.
- Other trials for Intravitreal Bevacizumab InjectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi Modarres, MD, Study director, Iran University of Medical Sciences(IUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548197
- Sponsor's protocol ID
- 85-A-57
- Status last verified
- Feb 2007
- First submitted
- 22 Oct 2007
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.
PubMed 16508426Castellarin A, Grigorian R, Bhagat N, Del Priore L, Zarbin MA. Vitrectomy with silicone oil infusion in severe diabetic retinopathy. Br J Ophthalmol. 2003 Mar;87(3):318-21. doi: 10.1136/bjo.87.3.318.
PubMed 12598446Grisanti S, Biester S, Peters S, Tatar O, Ziemssen F, Bartz-Schmidt KU; Tuebingen Bevacizumab Study Group. Intracameral bevacizumab for iris rubeosis. Am J Ophthalmol. 2006 Jul;142(1):158-60. doi: 10.1016/j.ajo.2006.02.045.
PubMed 16815268
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
- ClinicalTrials.gov ID
- NCT00548197
- Acronym / sponsor ID
- 85-A-57
- Conditions
- Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment, Diabetic Retinopathy
- Keywords
- Intravitreal Bevacizumab injection, Pars plana vitrectomy, tractional retinal detachment, Diabetic retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.
Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..
In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.
During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.
Detailed description
Eligibility criteria:
Diabetic tractional retinal detachment-complexity score between 4 and 8
Main outcome measures:
best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: BevacizumabIntravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy |
| Control group | No intervention | –no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.
- Complexity score between 4 and 8.
Key exclusion criteria (2 listed)
- Previous vitreoretinal surgery.
- Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.
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 |
|---|---|---|
| BevacizumabAlso: Brand name of Bevacizumab is Avastinone intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy | Drug | Intervention group |
Primary outcome
Best Corrected Visual Acuity
Time frame: last follow up, an average of 7 months post-operation
Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
1 secondary outcome
Anatomic Status of the Retina
Time frame: Last follow up, an average of 7 months post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16508426Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.
- Background: PubMed 12598446Castellarin A, Grigorian R, Bhagat N, Del Priore L, Zarbin MA. Vitrectomy with silicone oil infusion in severe diabetic retinopathy. Br J Ophthalmol. 2003 Mar;87(3):318-21. doi: 10.1136/bjo.87.3.318.
- Background: PubMed 16815268Grisanti S, Biester S, Peters S, Tatar O, Ziemssen F, Bartz-Schmidt KU; Tuebingen Bevacizumab Study Group. Intracameral bevacizumab for iris rubeosis. Am J Ophthalmol. 2006 Jul;142(1):158-60. doi: 10.1016/j.ajo.2006.02.045.
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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.
Mehdi Modarres, MD study director
Iran University of Medical Sciences(IUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab in people with Intravitreal Bevacizumab Injection and Pars Plana Vitrectomy, run by Iran University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 2 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 16 Oct 2018. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2018). 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?
Best Corrected Visual Acuity (time frame: last follow up, an average of 7 months post-operation). 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 NCT00548197, which also lists 3 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 16 Oct 2018.