Tractional Retinal Detachment Secondary to Proliferative Diabetic RetinopathyPhase 3NCT01976923
Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
A Phase 3 study testing Intravitreal bevacizumab and Small-gauge pars plana vitrectomy in people with Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy, run by J. Fernando Arevalo, MD FACS at 1 site in Saudi Arabia.
Trial summary
The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
- What is being tested?
- Intravitreal bevacizumab and Small-gauge pars plana vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2013to Oct 2018
- 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
- Age >= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
- Diagnosis of diabetes mellitus (type 1 or type 2)
- At least one eye meets the study eye criteria
- One eye per patient will be included
- Able and willing to provide informed consent prior to any study-related procedures
- Best corrected visual acuity 20/40 or less
- Willing and able to comply with clinic visits and study-related procedures
- U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws
Who cannot join
- Ocular Exclusion Criteria
- The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):
- TRD is considered to be due to a cause other than diabetes.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
- History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs.
Show all 33Show fewer
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization.
- History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization.
- Intraocular pressure >= 25 mmHg.
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or including hypertension, cardiovascular disease, and glycemic control.
- Systemic Exclusion Criteria
- A participant is not eligible if any of the following exclusion criteria are present:
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including hypertension, cardiovascular disease, and glycemic control).
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drug.
- Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drug.
- Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
- History of blood diseases associated with abnormal coagulation.
- Anti-coagulant therapy (warfarin or heparin).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group
The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In addition, post-operative rebleeding may be decreased.
Read the detailed description
This will be a prospective, randomized, active-controlled study of 224 eyes of patients with the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility. Eligible patients will be examined at baseline to determine their ocular condition and randomized into 2 arms. Patients will be randomized in a 1:1 ratio to the study arm.
- Control arm: PPV without pre-operative bevacizumab (Sham injection).
- Study arm: Pre-operative bevacizumab (3-5 days) before PPV.
In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS).
The purpose of the current study is to determine the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR.
- Being tested
- Intravitreal bevacizumab, Small-gauge pars plana vitrectomy
- Keywords
- Intravitreal Bevacizumab, Tractional Retinal Detachment, Proliferative Diabetic Retinopathy, Small gauge pars plana vitrectomy, Intraoperative bleeding, Post-operative vitreous hemorrhage, Visual acuity
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal bevacizumabDrug
A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.
Small-gauge pars plana vitrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Active comparator | Intravitreal bevacizumab Small-gauge pars plana vitrectomy Receives: Drug: Intravitreal bevacizumab; Procedure: Small-gauge pars plana vitrectomy |
| Control arm | Sham comparator | Small-gauge pars plana vitrectomy Receives: Procedure: Small-gauge pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding
Measured: 12 months
Total surgical time
Measured: 12 months
Post-operative vitreous hemorrhage
Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
Measured: 12 months
Visual acuity change
Mean change in best-corrected visual acuity (BCVA) at 12 months
Measured: 12 months
Secondary outcomes (4)
Number of endodiathermy applications
Measured: 12 months
Intraoperative breaks
Measured: 12 months
Change in central macular thickness
Measured: 12 months
Proportion of eyes gaining at least 15 letters of BCVA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2018
- Study completionOct 2018
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 Tractional Retinal Detachment Secondary to 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Fernando Arevalo, MD FACS
- Sponsor type
- Other government
- Collaborators
- Pan American Collaborative Retina Study Group
- Responsible party
- Sponsor-investigator, J. Fernando Arevalo, MD FACS, King Khaled Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976923
- Sponsor's protocol ID
- 1338-P
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2013
- Last updated
- 9 Oct 2018
- Results posted
- No
Publications
Arevalo JF, Sanchez JG, Saldarriaga L, Berrocal MH, Fromow-Guerra J, Morales-Canton V, Wu L, Maia M, Saravia MJ, Bareno J; Pan American Collaborative Retina Study Group. Retinal detachment after bevacizumab. Ophthalmology. 2011 Nov;118(11):2304.e3-7. doi: 10.1016/j.ophtha.2011.05.015. No abstract available.
PubMed 22047908Arevalo JF, Sanchez JG, Lasave AF, Wu L, Maia M, Bonafonte S, Brito M, Alezzandrini AA, Restrepo N, Berrocal MH, Saravia M, Farah ME, Fromow-Guerra J, Morales-Canton V. Intravitreal Bevacizumab (Avastin) for Diabetic Retinopathy: The 2010 GLADAOF Lecture. J Ophthalmol. 2011;2011:584238. doi: 10.1155/2011/584238. Epub 2011 Mar 30.
PubMed 21584260Arevalo JF, Garcia-Amaris RA. Intravitreal bevacizumab for diabetic retinopathy. Curr Diabetes Rev. 2009 Feb;5(1):39-46. doi: 10.2174/157339909787314121.
PubMed 19199897Arevalo JF, Maia M, Flynn HW Jr, Saravia M, Avery RL, Wu L, Eid Farah M, Pieramici DJ, Berrocal MH, Sanchez JG. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008 Feb;92(2):213-6. doi: 10.1136/bjo.2007.127142. Epub 2007 Oct 26.
PubMed 17965108
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group
- ClinicalTrials.gov ID
- NCT01976923
- Acronym / sponsor ID
- 1338-P
- Keywords
- Intravitreal Bevacizumab, Tractional Retinal Detachment, Proliferative Diabetic Retinopathy, Small gauge pars plana vitrectomy, Intraoperative bleeding, Post-operative vitreous hemorrhage, Visual acuity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- J. Fernando Arevalo, MD FACSOther government
- Collaborators
- Pan American Collaborative Retina Study Group
- Study start
- Nov 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Nov 2013 (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 is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In addition, post-operative rebleeding may be decreased.
Detailed description
This will be a prospective, randomized, active-controlled study of 224 eyes of patients with the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility. Eligible patients will be examined at baseline to determine their ocular condition and randomized into 2 arms. Patients will be randomized in a 1:1 ratio to the study arm.
- Control arm: PPV without pre-operative bevacizumab (Sham injection).
- Study arm: Pre-operative bevacizumab (3-5 days) before PPV.
In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS).
The purpose of the current study is to determine the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Active comparator | Drug: Intravitreal bevacizumab, Procedure: Small-gauge pars plana vitrectomyIntravitreal bevacizumab Small-gauge pars plana vitrectomy |
| Control arm | Sham comparator | Procedure: Small-gauge pars plana vitrectomySmall-gauge pars plana vitrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
- Diagnosis of diabetes mellitus (type 1 or type 2)
- At least one eye meets the study eye criteria
- One eye per patient will be included
- Able and willing to provide informed consent prior to any study-related procedures
Key exclusion criteria (33 listed)
- Ocular Exclusion Criteria
- The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):
- TRD is considered to be due to a cause other than diabetes.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
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 |
|---|---|---|
| Intravitreal bevacizumabA sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus. | Drug | Study arm |
| Small-gauge pars plana vitrectomy | Procedure or surgery | Control arm, Study arm |
Primary outcome
Intraoperative bleeding
Time frame: 12 months
Total surgical time
Time frame: 12 months
Post-operative vitreous hemorrhage
Time frame: 12 months
Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
Visual acuity change
Time frame: 12 months
Mean change in best-corrected visual acuity (BCVA) at 12 months
4 secondary outcomes
Number of endodiathermy applications
Time frame: 12 months
Intraoperative breaks
Time frame: 12 months
Change in central macular thickness
Time frame: 12 months
Proportion of eyes gaining at least 15 letters of BCVA
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Background: PubMed 22047908Arevalo JF, Sanchez JG, Saldarriaga L, Berrocal MH, Fromow-Guerra J, Morales-Canton V, Wu L, Maia M, Saravia MJ, Bareno J; Pan American Collaborative Retina Study Group. Retinal detachment after bevacizumab. Ophthalmology. 2011 Nov;118(11):2304.e3-7. doi: 10.1016/j.ophtha.2011.05.015. No abstract available.
- Background: PubMed 21584260Arevalo JF, Sanchez JG, Lasave AF, Wu L, Maia M, Bonafonte S, Brito M, Alezzandrini AA, Restrepo N, Berrocal MH, Saravia M, Farah ME, Fromow-Guerra J, Morales-Canton V. Intravitreal Bevacizumab (Avastin) for Diabetic Retinopathy: The 2010 GLADAOF Lecture. J Ophthalmol. 2011;2011:584238. doi: 10.1155/2011/584238. Epub 2011 Mar 30.
- Background: PubMed 19199897Arevalo JF, Garcia-Amaris RA. Intravitreal bevacizumab for diabetic retinopathy. Curr Diabetes Rev. 2009 Feb;5(1):39-46. doi: 10.2174/157339909787314121.
- Background: PubMed 17965108Arevalo JF, Maia M, Flynn HW Jr, Saravia M, Avery RL, Wu L, Eid Farah M, Pieramici DJ, Berrocal MH, Sanchez JG. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008 Feb;92(2):213-6. doi: 10.1136/bjo.2007.127142. Epub 2007 Oct 26.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravitreal bevacizumab and Small-gauge pars plana vitrectomy in people with Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy, run by J. Fernando Arevalo, MD FACS at 1 site in Saudi Arabia.
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 8 inclusion and 33 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 9 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 Saudi Arabia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraoperative bleeding (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT01976923, 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 9 Oct 2018.