Diabetic RetinopathyPhase 2VITARMNCT00931125
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
A Phase 2 study testing ranibizumab and vitrectomy and vitrectomy without preoperative ranibizumab in people with Diabetic Retinopathy, run by Attila Vajas at 1 site in Hungary.
Trial summary
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- ranibizumab and vitrectomy and vitrectomy without preoperative ranibizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female 18 or older who have signed an informed consent
- Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
- study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
- study eye vision decrease must be resulted from severe PDR
Who cannot join
- Active ocular inflammation or infection
- History of uveitis
- Uncontrolled glaucoma
- High myopia
- Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
- Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
Show all 17Show fewer
- History of vitrectomy within 60 days preceding Day 1 in the study eye
- History of intraocular surgery within 30 days preceding Day 1 in the study eye
- Untreated diabetes mellitus
- Severe hypertension (systolic pressure higher than 160mmHg)
- Current use of systemic medications known to be toxic to the retina
- History of thromboembolic events (incl MI and stroke) within 5 years
- Major surgery within previous 3 months or planned within the next 28 days
- Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
- Known hypersensitivity to ranibizumab or any component of it
- Women of childbearing potential unless 2 methods of birth control applied
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
Debrecen, H-4012
About this study
Official title: Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
Read the detailed description
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
- Conditions
- Diabetic Retinopathy
- Being tested
- ranibizumab and vitrectomy, vitrectomy without preoperative ranibizumab
- Keywords
- Severe proliferative diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab and vitrectomyDrug
Also called Lucentis intravitreal injection.
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
vitrectomy without preoperative ranibizumabProcedure or surgery
sham intravitreal injection before vitrectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| vitrectomy with ranibizumab | Active comparator | Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery Receives: Drug: ranibizumab and vitrectomy |
| vitrectomy without ranibizumab | Placebo comparator | Patients receiving sham treatment before vitrectomy as a comparator arm Receives: Procedure: vitrectomy without preoperative ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of preoperative intravitreal ranibizumab
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
Measured: OP day
Secondary outcomes (4)
Change in BCVA.
Measured: 6 months
Effect in anatomical changes.
Measured: 3 ±1 days after injection
Safety.
Measured: Over 6 months.
Retinal circulation integrity.
Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )
Measured: Month 1, 3, 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2013
- Study completionDec 2013 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attila Vajas
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Sponsor-investigator, Attila Vajas, University of Debrecen
- Investigators
- Attila Vajas, MD, Principal investigator, National Institute of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931125
- Sponsor's protocol ID
- CRFB002AHU03T
- Acronym
- VITARM
- Status last verified
- Oct 2013
- First submitted
- 1 Jul 2009
- Last updated
- 16 Oct 2013
- 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 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
- ClinicalTrials.gov ID
- NCT00931125
- Acronym / sponsor ID
- VITARM / CRFB002AHU03T
- Conditions
- Diabetic Retinopathy
- Keywords
- Severe proliferative diabetic retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Attila VajasUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- Mar 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Jul 2009 (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 investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
Detailed description
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitrectomy with ranibizumab | Active comparator | Drug: ranibizumab and vitrectomyPatients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery |
| vitrectomy without ranibizumab | Placebo comparator | Procedure: vitrectomy without preoperative ranibizumabPatients receiving sham treatment before vitrectomy as a comparator arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female 18 or older who have signed an informed consent
- Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
- study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
- study eye vision decrease must be resulted from severe PDR
Key exclusion criteria (17 listed)
- Active ocular inflammation or infection
- History of uveitis
- Uncontrolled glaucoma
- High myopia
- Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
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 |
|---|---|---|
| ranibizumab and vitrectomyAlso: Lucentis intravitreal injection.ranibizumab 10mg/ml intravitreal injection, 0,05 ml | Drug | vitrectomy with ranibizumab |
| vitrectomy without preoperative ranibizumabsham intravitreal injection before vitrectomy surgery | Procedure or surgery | vitrectomy without ranibizumab |
Primary outcome
Efficacy of preoperative intravitreal ranibizumab
Time frame: OP day
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
4 secondary outcomes
Change in BCVA.
Time frame: 6 months
Effect in anatomical changes.
Time frame: 3 ±1 days after injection
Safety.
Time frame: Over 6 months.
Retinal circulation integrity.
Time frame: Month 1, 3, 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- 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.
Attila Vajas, MD principal investigator
National Institute of Pharmacy
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 ranibizumab and vitrectomy and vitrectomy without preoperative ranibizumab in people with Diabetic Retinopathy, run by Attila Vajas at 1 site in Hungary.
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 17 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: status not confirmed, as of the sponsor's last update on 16 Oct 2013. 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 Hungary. 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?
Results are not available in the source record.
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?
Efficacy of preoperative intravitreal ranibizumab (time frame: OP day). 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 NCT00931125, 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 16 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.