Diabetic RetinopathyPhase 4RaDiVitNCT01306981
Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study
A Phase 4 study testing Ranibizumab and Saline in people with Diabetic Retinopathy and Retinal Neovascularisation, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy. Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Retinal Neovascularisation
- What is being tested?
- Ranibizumab and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Mar 2011to 12 Mar 2013
- Phase
- Phase 4
- 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
- Patients of either sex aged 18 years or over
- Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes
- Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes)
- Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes
- Ability to return for study visits
- Ability to give informed consent throughout the duration of the study
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients.
- Active or suspected ocular or periocular infections.
- Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment
- Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery
- Active severe intraocular inflammation
- Previous vitrectomy surgery on study eye
Show all 12Show fewer
- Vision in fellow eye 3/60 or worse
- Uncontrolled glaucoma
- History of stroke, peripheral vascular disease, angina or myocardial infarction within six months prior to randomisation
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
- Pregnancy or lactation
- Male or female unwilling to use contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study
This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy.
Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Our hypothesis is that injection into the eye of ranibizumab one week before surgery will make the surgery easier, reduce complications and improve outcome.
In this trial, patients will be randomly allocated to receive either ranibizumab injection or a placebo injection of saline. Neither the patient, their surgeon, nor the study investigators will know which they have received so that a fair comparison can be made.
Read the detailed description
The RaDiVit study is a pilot randomised controlled trial to evaluate the effect of ranibizumab as an adjunct to diabetic vitrectomy surgery.
Patients with complications of proliferative diabetic retinopathy who require vitrectomy surgery will be recruited to this study. Baseline tests will be performed, including refracted visual acuity, B-scan ultrasound, OCT scanning, colour fundus photography and fundus fluorescein angiography. Patients will be randomised 1:1 to receive either ranibizumab intravitreal injection or saline subconjunctival injection.
One week later, surgery will be carried out. The baseline tests will be repeated on the day of surgery to examine for any discernible difference between the two groups one week after treatment. Surgery will be video recorded and detailed assessments of the operative details carried out.
A vitreous sample and a paired serum sample will be taken at the time of surgery to compare levels of ranibizumab and related cytokines.
Follow up visits will take place at six and twelve weeks. Assessments at that point will include:
- visual acuity
- OCT scan
- colour fundus photography and fundus fluorescein angiography
- Conditions
- Diabetic Retinopathy, Retinal Neovascularisation
- Being tested
- Ranibizumab, Saline
- Keywords
- Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Vitrectomy, Vitreoretinal Surgery
- Medical subject headings
- Diabetic Retinopathy, Retinal Neovascularization, Diabetes Mellitus, Diabetes Complications, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
SalineDrug
Subconjunctival injection of 0.05ml saline 0.9% w/v
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Not described Receives: Drug: Ranibizumab |
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured: 12 weeks post-op
Secondary outcomes (8)
Ease of performing vitrectomy surgery
Assessed by surgical scoring systems and counting tool usage
Measured: One week post injection
Incidence of post-operative vitreous haemorrhage
Measured: 6 weeks post-op
Extent of retinal neovascularisation
Measured: 6 weeks post-op
Extent of tractional retinal detachment
Assessed by serial B-scan ultrasound
Measured: 1 week post-injection
Extent of macular perfusion
Assessed by fundus fluorescein angiography
Measured: 12 weeks post-op
Vitreous and serum levels of ranibizumab and related cytokines
Samples to be taken on day of surgery
Measured: One week post-injection
Incidence of post-operative vitreous haemorrhage
Measured: 12 weeks post-op
Extent of retinal neovascularisation
Measured: 12 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study start30 Mar 2011
- Primary completionMar 2013
- Study completion12 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- James W Bainbridge, MA PhD FRCOphth, Principal investigator, Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306981
- Sponsor's protocol ID
- BAIJ1006
- Acronym
- RaDiVit
- Status last verified
- Sep 2020
- First submitted
- 1 Mar 2011
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study
- ClinicalTrials.gov ID
- NCT01306981
- Acronym / sponsor ID
- RaDiVit / BAIJ1006
- Conditions
- Diabetic Retinopathy, Retinal Neovascularisation
- Keywords
- Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Vitrectomy, Vitreoretinal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 30 Mar 2011 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- 12 Mar 2013 (actual)
- First posted
- 2 Mar 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.
This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy.
Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Our hypothesis is that injection into the eye of ranibizumab one week before surgery will make the surgery easier, reduce complications and improve outcome.
In this trial, patients will be randomly allocated to receive either ranibizumab injection or a placebo injection of saline. Neither the patient, their surgeon, nor the study investigators will know which they have received so that a fair comparison can be made.
Detailed description
The RaDiVit study is a pilot randomised controlled trial to evaluate the effect of ranibizumab as an adjunct to diabetic vitrectomy surgery.
Patients with complications of proliferative diabetic retinopathy who require vitrectomy surgery will be recruited to this study. Baseline tests will be performed, including refracted visual acuity, B-scan ultrasound, OCT scanning, colour fundus photography and fundus fluorescein angiography. Patients will be randomised 1:1 to receive either ranibizumab intravitreal injection or saline subconjunctival injection.
One week later, surgery will be carried out. The baseline tests will be repeated on the day of surgery to examine for any discernible difference between the two groups one week after treatment. Surgery will be video recorded and detailed assessments of the operative details carried out.
A vitreous sample and a paired serum sample will be taken at the time of surgery to compare levels of ranibizumab and related cytokines.
Follow up visits will take place at six and twelve weeks. Assessments at that point will include:
- visual acuity
- OCT scan
- colour fundus photography and fundus fluorescein angiography
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 |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of either sex aged 18 years or over
- Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes
- Ability to return for study visits
- Ability to give informed consent throughout the duration of the study
Key exclusion criteria (12 listed)
- Hypersensitivity to the active substance or to any of the excipients.
- Active or suspected ocular or periocular infections.
- Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment
- Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery
- Active severe intraocular inflammation
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 |
|---|---|---|
| RanibizumabAlso: LucentisIntravitreal injection of ranibizumab, 0.5mg in 0.05ml | Drug | Ranibizumab |
| SalineSubconjunctival injection of 0.05ml saline 0.9% w/v | Drug | Saline |
Primary outcome
Best corrected visual acuity
Time frame: 12 weeks post-op
8 secondary outcomes
Ease of performing vitrectomy surgery
Time frame: One week post injection
Incidence of post-operative vitreous haemorrhage
Time frame: 6 weeks post-op
Extent of retinal neovascularisation
Time frame: 6 weeks post-op
Extent of tractional retinal detachment
Time frame: 1 week post-injection
Extent of macular perfusion
Time frame: 12 weeks post-op
Vitreous and serum levels of ranibizumab and related cytokines
Time frame: One week post-injection
Incidence of post-operative vitreous haemorrhage
Time frame: 12 weeks post-op
Extent of retinal neovascularisation
Time frame: 12 weeks post-op
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 Sep 2020.
- 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.
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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.
James W Bainbridge, MA PhD FRCOphth principal investigator
Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab and Saline in people with Diabetic Retinopathy and Retinal Neovascularisation, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 12 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 Sep 2020. 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 Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Best corrected visual acuity (time frame: 12 weeks post-op). 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 NCT01306981, 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 9 Sep 2020.