Proliferative Diabetic Retinopathy - High RiskPostop IVANCT06899529
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
A study testing Bevacizumab in people with Proliferative Diabetic Retinopathy - High Risk, run by Christian Ophthalmic Surgery Expedition Network at 1 site in Mexico.
Trial summary
Patients undergoing surgery for complications related to diabetes will be recruited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy - High Risk
- What is being tested?
- Bevacizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 20 Mar 2025to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject age is > 18
- Subject consents to study participation and is capable of 6 months of follow-up.
- The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye.
- The subject is determined to need a PPV because of reduced BCSVA principally from a non-clearing vitreous hemorrhage, TRD, fibrous proliferation, or a combination of the three. When non-clearing vitreous hemorrhage is the principal reason for PPV, the hemorrhage must have been present by subjective history for at least 3 months. When TRD is the principal reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the principal reason for PPV, it must be extensive (>3 clock hours) and threatening (within one disc diameter) or involving the fovea.
- Only one eye per patient is eligible for the study.
Who cannot join
- Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
- Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
- Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
- Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christi Rush contact
Mexico1 site, 1 recruiting
- Recruiting
Sky Vision
Querétaro City, Querétaro, 76165
Isaac Aleman, MD, 52 662 157 0950, choseneyemission@gmail.com
Christi Rush, 8066740200, christirush123@gmail.com
About this study
Patients undergoing surgery for complications related to diabetes will be recruited.
Read the detailed description
Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be randomized whether or not to receive intravitreal bevacizumab at the conclusion of the operation.
- Being tested
- Bevacizumab
- Keywords
- proliferative diabetic retinopathy, bevacizumab, 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.
BevacizumabProcedure or surgery
Bevacizumab will be given immediately after surgery in the Treatment Group
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Receives postoperative bevacizumab Receives: Procedure: Bevacizumab |
| Control Group | No intervention | Does NOT receive postoperative bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Postoperative vitreous hemorrhage rate
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 posted28 Mar 2025
- Study start20 Mar 2025
- Primary completion20 Mar 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic Retinopathy - High RiskStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Prospective Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Ophthalmic Surgery Expedition Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Aleman, MD, Principal investigator, Christian Ophthalmic Surgery Expedition Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899529
- Sponsor's protocol ID
- IORG0009239-1
- Acronym
- Postop IVA
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not sure at this point.
Publications
Aleman I, Castillo Velazquez J, Rush SW, Rush RB. Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial. Br J Ophthalmol. 2019 Dec;103(12):1740-1746. doi: 10.1136/bjophthalmol-2018-313313. Epub 2019 Jan 31.
PubMed 30705040Castillo Velazquez J, Aleman I, Rush SW, Rush RB. Bevacizumab before Diabetic Vitrectomy: A Clinical Trial Assessing 3 Dosing Amounts. Ophthalmol Retina. 2018 Oct;2(10):1010-1020. doi: 10.1016/j.oret.2018.04.014. Epub 2018 Oct 3.
PubMed 31047488Castillo J, Aleman I, Rush SW, Rush RB. Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: A Randomized and Controlled Trial Comparing Interval Variation. Am J Ophthalmol. 2017 Nov;183:1-10. doi: 10.1016/j.ajo.2017.08.013. Epub 2017 Aug 30.
PubMed 28860046
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
- ClinicalTrials.gov ID
- NCT06899529
- Acronym / sponsor ID
- Postop IVA / IORG0009239-1
- Keywords
- proliferative diabetic retinopathy, bevacizumab, vitreous hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Christian Ophthalmic Surgery Expedition NetworkUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- 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.
Patients undergoing surgery for complications related to diabetes will be recruited.
Detailed description
Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be randomized whether or not to receive intravitreal bevacizumab at the conclusion of the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Prospective Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Procedure: BevacizumabReceives postoperative bevacizumab |
| Control Group | No intervention | –Does NOT receive postoperative bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject age is > 18
- Subject consents to study participation and is capable of 6 months of follow-up.
- The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye.
- The subject is determined to need a PPV because of reduced BCSVA principally from a non-clearing vitreous hemorrhage, TRD, fibrous proliferation, or a combination of the three. When non-clearing vitreous hemorrhage is the principal reason for PPV, the hemorrhage must have been present by subjective history for at least 3 months. When TRD is the principal reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the principal reason for PPV, it must be extensive (>3 clock hours) and threatening (within one disc diameter) or involving the fovea.
Key exclusion criteria (6 listed)
- Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
- Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
- Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
- Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
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 |
|---|---|---|
| BevacizumabBevacizumab will be given immediately after surgery in the Treatment Group | Procedure or surgery | Treatment Group |
Primary outcome
Primary Outcome
Time frame: 6 months
Postoperative vitreous hemorrhage rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Results publication: PubMed 30705040Aleman I, Castillo Velazquez J, Rush SW, Rush RB. Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial. Br J Ophthalmol. 2019 Dec;103(12):1740-1746. doi: 10.1136/bjophthalmol-2018-313313. Epub 2019 Jan 31.
- Results publication: PubMed 31047488Castillo Velazquez J, Aleman I, Rush SW, Rush RB. Bevacizumab before Diabetic Vitrectomy: A Clinical Trial Assessing 3 Dosing Amounts. Ophthalmol Retina. 2018 Oct;2(10):1010-1020. doi: 10.1016/j.oret.2018.04.014. Epub 2018 Oct 3.
- Results publication: PubMed 28860046Castillo J, Aleman I, Rush SW, Rush RB. Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: A Randomized and Controlled Trial Comparing Interval Variation. Am J Ophthalmol. 2017 Nov;183:1-10. doi: 10.1016/j.ajo.2017.08.013. Epub 2017 Aug 30.
- Individual participant dataSharing planned: Undecided. Not sure at this point.
Related trials for Proliferative Diabetic Retinopathy - High Risk
Active, not recruitingPhase 4
High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 4
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Diabetic Macular Edema (DME)
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.
Christi Rush contact
Isaac Aleman, MD principal investigator
Christian Ophthalmic Surgery Expedition Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab in people with Proliferative Diabetic Retinopathy - High Risk, run by Christian Ophthalmic Surgery Expedition Network at 1 site in Mexico.
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 6 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. 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 Mexico. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Rush, MD (18066740200, chosenmedical@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (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 NCT06899529, 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 28 Mar 2025.