Proliferative Diabetic RetinopathyPhase 2NCT01478737
Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
A Phase 2 study testing Intravitreal dexamethasone implant and Vitrectomy in people with Proliferative Diabetic Retinopathy, run by Anders Kvanta at 1 site in Sweden.
Trial summary
To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Intravitreal dexamethasone implant and Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Apr 2016
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with vitreous hemorrhage undergoing PPV for PDRP
Who cannot join
- Previous PPV
- Vitreous hemorrhage of non-PDRP origin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).
Read the detailed description
To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Intravitreal dexamethasone implant, Vitrectomy
- Keywords
- PDRP, vitreous hemorrhage, vitrectomy
- 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 dexamethasone implantDrug
Also called OZURDEX® (dexamethasone intravitreal implant)
Intravitreal Ozurdex after vitrectomy
VitrectomyProcedure or surgery
Vitrectomy only
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Vitrectomy only Receives: Procedure: Vitrectomy |
| Intravitreal Ozurdex | Active comparator | Intravitreal Ozurdex after vitrectomy Receives: Drug: Intravitreal dexamethasone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
The proportion of patients that, due to re-bleeding within 12 months, have a second PPV
Measured: 12 months
Secondary outcomes (1)
Rebleeding
The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously
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 posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Kvanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Kvanta, St. Erik Eye Hospital
- Investigators
- Anders Kvanta, PhD, Principal investigator, St. Erik Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478737
- Sponsor's protocol ID
- PDRPOZU1
- Status last verified
- Jan 2024
- First submitted
- 21 Nov 2011
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01478737
- Acronym / sponsor ID
- PDRPOZU1
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- PDRP, vitreous hemorrhage, vitrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Anders KvantaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Nov 2011 (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.
To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).
Detailed description
To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Procedure: VitrectomyVitrectomy only |
| Intravitreal Ozurdex | Active comparator | Drug: Intravitreal dexamethasone implantIntravitreal Ozurdex after vitrectomy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with vitreous hemorrhage undergoing PPV for PDRP
Key exclusion criteria (2 listed)
- Previous PPV
- Vitreous hemorrhage of non-PDRP origin
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 dexamethasone implantAlso: OZURDEX® (dexamethasone intravitreal implant)Intravitreal Ozurdex after vitrectomy | Drug | Intravitreal Ozurdex |
| VitrectomyVitrectomy only | Procedure or surgery | Sham |
Primary outcome
Reoperation
Time frame: 12 months
The proportion of patients that, due to re-bleeding within 12 months, have a second PPV
1 secondary outcome
Rebleeding
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 30 Jan 2024.
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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.
Anders Kvanta, PhD principal investigator
St. Erik Eye Hospital
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 dexamethasone implant and Vitrectomy in people with Proliferative Diabetic Retinopathy, run by Anders Kvanta at 1 site in Sweden.
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 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 30 Jan 2024. 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 Sweden. 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 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?
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?
Reoperation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024.