Vitreous HemorrhagePhase 2NCT01805297
Aflibercept Injection for Proliferative Diabetic Retinopathy
A Phase 2 study testing Intravitreal Aflibercept Injection and Standard Vitrectomy in people with Vitreous Hemorrhage, run by University of Oklahoma at 1 site in United States.
Trial summary
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreous Hemorrhage
- What is being tested?
- Intravitreal Aflibercept Injection and Standard Vitrectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2015
- Phase
- Phase 2
- 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV)
- Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Who cannot join
- Pregnancy (positive urine pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
- Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study
- For previously treated subjects -
- Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening
- Prior treatment with triamcinolone in the study eye within 6 months of Screening.
Show all 18Show fewer
- Prior treatment with dexamethasone in the study eye within 30 days of Screening
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for PDR in the study eye
- Active intraocular inflammation (grade trace or above) in the study eye
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
- History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to treatment
- Presence of macular traction
- Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV)
- Concomitant use of any systemic anti-VEGF therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
About this study
Official title: Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Read the detailed description
Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.
- Conditions
- Vitreous Hemorrhage
- Being tested
- Intravitreal Aflibercept Injection, Standard Vitrectomy
- Keywords
- Proliferative Diabetic Retinopathy
- Medical subject headings
- Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept InjectionDrug
Also called Eylea
One time 2.0mg aflibercept injection, following pars plana vitrectomy.
Standard VitrectomyOther
Surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy with Aflibercept Injection | Active comparator | Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. Receives: Drug: Intravitreal Aflibercept Injection |
| Standard Vitrectomy | Active comparator | Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. Receives: Other: Standard Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Resolved Post-operative Vitreous Hemorrhage.
Percentage of patients who had no vitreous hemorrhage before or at week 24
Measured: 24 weeks
Secondary outcomes (3)
Mean Change in Visual Acuity
Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased.
Measured: 24 weeks
Need for Any Additional Surgical Intervention.
Measured: 24 weeks
Changes in Mean Central Retinal Thickness.
The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionNov 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Vitreous HemorrhageStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert E Leonard, MD, Principal investigator, Dean McGee Eye InstituteVinay A Shah, MD, Principal investigator, Dean McGee Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805297
- Sponsor's protocol ID
- 2148
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2013
- Last updated
- 27 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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 37260074
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01805297
- Acronym / sponsor ID
- 2148
- Conditions
- Vitreous Hemorrhage
- Keywords
- Proliferative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Detailed description
Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy with Aflibercept Injection | Active comparator | Drug: Intravitreal Aflibercept InjectionPreoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. |
| Standard Vitrectomy | Active comparator | Other: Standard VitrectomyPreoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV)
- Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Key exclusion criteria (18 listed)
- Pregnancy (positive urine pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
- Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study
- For previously treated subjects -
- Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening
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 Aflibercept InjectionAlso: EyleaOne time 2.0mg aflibercept injection, following pars plana vitrectomy. | Drug | Vitrectomy with Aflibercept Injection |
| Standard VitrectomySurgical intervention | Other | Standard Vitrectomy |
Primary outcome
Rate of Resolved Post-operative Vitreous Hemorrhage.
Time frame: 24 weeks
Percentage of patients who had no vitreous hemorrhage before or at week 24
3 secondary outcomes
Mean Change in Visual Acuity
Time frame: 24 weeks
Need for Any Additional Surgical Intervention.
Time frame: 24 weeks
Changes in Mean Central Retinal Thickness.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- 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.
- Individual participant dataSharing planned: No
Related trials for Vitreous Hemorrhage
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
Not yet recruitingObservational study
Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
Cataract, Vitreous Hemorrhage
Not yet recruitingPhase 4
Continuous Delivery of Ranibizumab Via the Port Delivery System for Proliferative Diabetic Retinopathy-related Vitreous Hemorrhage With Pars Plana Vitrectomy and Limited PRP.
Proliferative Diabetic Retinopathy, Diabetic Retinopathy
Enrolling by invitationPhase 4
Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
Diabetic Retinopathy, Vitreous Hemorrhage Due to Diabetes Mellitus
Recruiting
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Proliferative Diabetic Retinopathy - High Risk
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.
Robert E Leonard, MD principal investigator
Dean McGee Eye Institute
Vinay A Shah, MD principal investigator
Dean McGee Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal Aflibercept Injection and Standard Vitrectomy in people with Vitreous Hemorrhage, run by University of Oklahoma 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 18 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 27 Dec 2023. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Sep 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?
Rate of Resolved Post-operative Vitreous Hemorrhage. (time frame: 24 weeks). 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 NCT01805297, which also lists 1 linked publication.
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 27 Dec 2023.