Diabetic RetinopathyPhase 4NCT01824043
Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage
A Phase 4 study testing intravitreal ranibizumab injections in people with Diabetic Retinopathy and Vitreous Hemorrhage, run by Hospital Regional de São José - Dr. Homero de Miranda Gomes at 1 site in Brazil.
Trial summary
Primary Objective: To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Retinopathy, Vitreous Hemorrhage
- What is being tested?
- intravitreal ranibizumab injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients >18 years of age who have signed an informed consent
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
- Patients with visual impairment due to vitreous hemorrhage.
- Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
Who cannot join
- Ocular concomitant conditions/ diseases
- Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
- Active intraocular inflammation (grade trace or above) in either eye
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- History of uveitis in either eye
- Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age-related macular degeneration, ocular histoplasmosis, or pathologic myopia)
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- Uncontrolled glaucoma in the study eye (according to investigator's judgment)
- Neovascularization of the iris in study eye
- Evidence of vitreomacular traction in study eye
- Ocular treatments
- Panretinal laser photocoagulation in the study eye within 6 months or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
- Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to randomization
- Any intraocular surgery in the study eye within 3 months prior to randomization
- History of vitrectomy in study eye
- Phakic study eye with a history of intravitreal corticosteroid treatment
- Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
- Systemic conditions or treatments
- History of disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the patient at high risk from treatment complications
- Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels >2.0 mg/dl
- Untreated diabetes mellitus
- Severe (blood pressure systolic > 160 mmHg OR diastolic > 100 mmHg) AND untreated hypertension
- Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation or to fluorescein contrast.
- Compliance/ Administrative
- Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to randomization
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- Pregnant or nursing (lactating) women.
- Inability to comply with study or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Marcelo Novello
São José, Santa Catarina, 88103-901
MARCELO NOVELLO, mbnovell@yahoo.com
About this study
Official title: Pilot Study Investigating the Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage in Proliferative Diabetic Retinopathy
Primary Objective:
To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy.
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 3.
Secondary Objectives:
- To assess any differences in mean change in BCVA over time;
- To assess differences in vitreous transparency (amount of hemorrhage) with fundus angiography exam;
- To assess any differences in retinopathy severity level according to the Early Treatment Diabetic Retinopathy Study;
- To correlate the visual outcomes with serum glucose levels.
Read the detailed description
Written informed consent must be obtained before any study assessment is performed.
This study will have only one group of patients, with a total of twenty subjects stratified based on decreased visual acuity due to vitreous hemorrhage in proliferative diabetic retinopathy:
Stratus 1 (ten subjects): patients with low to moderate diabetic vitreous hemorrhage; Stratus 2 (ten subjects): patients with severe diabetic vitreous hemorrhage. Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports.
During regular, monthly visits, a detailed ophthalmologic evaluation will be performed, including a BCVA assessment. Vitreous hemorrhage density will also be assessed, according to the fundus visualization in retinal angiography:
- low to moderate vitreous hemorrhage: posterior pole detail slightly hazy or very hazy;
- severe vitreous hemorrhage: fundus details not visible. All patients with severe vitreous hemorrhage will have A/B ultrasound scan performed in the day of the injection. The intravitreal injection will always be the last procedure performed in a given day.
Blood samples will also be collected in each study visit, in order to assess serum glucose levels.
Laser treatment may be administered at investigator's discretion if vitreous hemorrhage reduce or disappear after the intravitreal treatment with ranibizumab to such a retinal fundus visibility level that permits photocoagulation.
All the patients of the study will be monitored about adverse events and will remain in their usual clinical and ophthalmological care after the end of the study.
Visit Schedule
Day0 Day30 Day 60 Day 90 Informed Consent X Ophthalmologic Examination X X X X Best Corrected Visual Acuity X X X X Fluorescein Angiography X X X X Serum Glucose Level X X X X A/B Ultrasound Scan X* X* X* Ranibizumab Injection X X X Laser Treatment
- ** Adverse Events Monitoring X X X X
- Only for patients that present severe vitreous hemorrhages.
- At investigator's discretion. Check the Methodology section for details.
Population:
Patients with proliferative diabetic retinopathy with vitreous hemorrhage.
- Conditions
- Diabetic Retinopathy, Vitreous Hemorrhage
- Being tested
- intravitreal ranibizumab injections
- Keywords
- diabetic retinopathy, vitreous hemorrhage, intravitreal ranibizumab
- Medical subject headings
- Diabetic Retinopathy, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal ranibizumab injectionsDrug
Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports
| Study group | Role | What they receive |
|---|---|---|
| vitreous hemorrhage group | Experimental | Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports Receives: Drug: intravitreal ranibizumab injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in visual acuity and transparence of vitreous in treated eyes.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de São José - Dr. Homero de Miranda Gomes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Brillinger Novello, Hospital Regional de São José - Dr. Homero de Miranda Gomes
- Investigators
- Marcelo Novello, Principal investigator, Hospital Regional Sao Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824043
- Sponsor's protocol ID
- LUBRAHV
- Status last verified
- Apr 2013
- First submitted
- 18 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Investigating the Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01824043
- Acronym / sponsor ID
- LUBRAHV
- Conditions
- Diabetic Retinopathy, Vitreous Hemorrhage
- Keywords
- diabetic retinopathy, vitreous hemorrhage, intravitreal ranibizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Regional de São José - Dr. Homero de Miranda GomesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Apr 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.
Primary Objective:
To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy.
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 3.
Secondary Objectives:
- To assess any differences in mean change in BCVA over time;
- To assess differences in vitreous transparency (amount of hemorrhage) with fundus angiography exam;
- To assess any differences in retinopathy severity level according to the Early Treatment Diabetic Retinopathy Study;
- To correlate the visual outcomes with serum glucose levels.
Detailed description
Written informed consent must be obtained before any study assessment is performed.
This study will have only one group of patients, with a total of twenty subjects stratified based on decreased visual acuity due to vitreous hemorrhage in proliferative diabetic retinopathy:
Stratus 1 (ten subjects): patients with low to moderate diabetic vitreous hemorrhage; Stratus 2 (ten subjects): patients with severe diabetic vitreous hemorrhage. Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports.
During regular, monthly visits, a detailed ophthalmologic evaluation will be performed, including a BCVA assessment. Vitreous hemorrhage density will also be assessed, according to the fundus visualization in retinal angiography:
- low to moderate vitreous hemorrhage: posterior pole detail slightly hazy or very hazy;
- severe vitreous hemorrhage: fundus details not visible. All patients with severe vitreous hemorrhage will have A/B ultrasound scan performed in the day of the injection. The intravitreal injection will always be the last procedure performed in a given day.
Blood samples will also be collected in each study visit, in order to assess serum glucose levels.
Laser treatment may be administered at investigator's discretion if vitreous hemorrhage reduce or disappear after the intravitreal treatment with ranibizumab to such a retinal fundus visibility level that permits photocoagulation.
All the patients of the study will be monitored about adverse events and will remain in their usual clinical and ophthalmological care after the end of the study.
Visit Schedule
Day0 Day30 Day 60 Day 90 Informed Consent X Ophthalmologic Examination X X X X Best Corrected Visual Acuity X X X X Fluorescein Angiography X X X X Serum Glucose Level X X X X A/B Ultrasound Scan X* X* X* Ranibizumab Injection X X X Laser Treatment
- ** Adverse Events Monitoring X X X X
- Only for patients that present severe vitreous hemorrhages.
- At investigator's discretion. Check the Methodology section for details.
Population:
Patients with proliferative diabetic retinopathy with vitreous hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitreous hemorrhage group | Experimental | Drug: intravitreal ranibizumab injectionsPatients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients >18 years of age who have signed an informed consent
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
- Patients with visual impairment due to vitreous hemorrhage.
- Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
Key exclusion criteria (28 listed)
- Ocular concomitant conditions/ diseases
- Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
- Active intraocular inflammation (grade trace or above) in either eye
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- History of uveitis in either eye
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 ranibizumab injectionsPatients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports | Drug | vitreous hemorrhage group |
Primary outcome
Gain in visual acuity and transparence of vitreous in treated eyes.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
Marcelo Novello principal investigator
Hospital Regional Sao Jose
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 intravitreal ranibizumab injections in people with Diabetic Retinopathy and Vitreous Hemorrhage, run by Hospital Regional de São José - Dr. Homero de Miranda Gomes at 1 site in Brazil.
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 28 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 4 Apr 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 Brazil. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Marcelo Novello, Chief (551832719094, mbnovell@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain in visual acuity and transparence of vitreous in treated eyes. (time frame: 90 days). 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 4 Apr 2013.