Diabetic Vitreous HemorrhagePhase 4RANI-VHNCT07690800
Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage
A Phase 4 study testing Ranibizumab in people with Diabetic Vitreous Hemorrhage and Intravitreal Injections, run by Benha University at 1 site in Egypt.
Trial summary
This prospective interventional cohort study evaluates the outcomes of intravitreal ranibizumab injection in patients with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Vitreous Hemorrhage, Intravitreal Injections, Ranibizumab
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Apr 2026
- 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
- Adults aged 20 to 70 years.
- Type 1 or Type 2 diabetes mellitus.
- Diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy.
- Treatment-naïve diabetic vitreous hemorrhage or recurrent/residual vitreous hemorrhage following previous panretinal photocoagulation.
- Phakic or pseudophakic eyes.
- Able and willing to provide written informed consent.
Who cannot join
- Significant tractional retinal detachment or retinal traction requiring immediate surgery.
- Previous ocular surgery other than cataract surgery.
- Previous intravitreal pharmacologic treatment within the preceding 6 months.
- Any type of glaucoma.
- Active ocular infection or significant ocular surface disease.
- No light perception vision.
- Known hypersensitivity to ranibizumab or any component of the study medication.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage: A Prospective Interventional Cohort Study
This prospective interventional cohort study evaluates the outcomes of intravitreal ranibizumab injection in patients with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy. The study aims to assess the effectiveness of ranibizumab in improving visual acuity, promoting vitreous hemorrhage clearance, reducing the need for pars plana vitrectomy, and evaluating treatment-related safety.
Eligible adult patients with diabetic vitreous hemorrhage will receive intravitreal ranibizumab according to the study protocol and will be followed for 3 to 6 months with serial ophthalmic examinations. Outcome measures include changes in best-corrected visual acuity, vitreous hemorrhage severity, treatment-related complications, and the proportion of patients requiring vitrectomy. Panretinal photocoagulation may be performed when adequate retinal visualization is achieved.
Read the detailed description
Diabetic vitreous hemorrhage is a common vision-threatening complication of proliferative diabetic retinopathy. Hemorrhage into the vitreous cavity results from fragile retinal neovascularization and may cause marked visual impairment while preventing adequate retinal examination and laser treatment. Although pars plana vitrectomy remains the standard treatment for persistent or non-clearing vitreous hemorrhage, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as a potential treatment option for selected patients.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), thereby reducing neovascular activity and vascular permeability. Suppression of VEGF may facilitate clearance of vitreous hemorrhage, improve visual acuity, allow subsequent panretinal photocoagulation, and reduce the need for vitrectomy.
This is a single-center prospective interventional cohort study conducted at the Ophthalmology Department of Benha University Hospital. Adult patients with diabetic vitreous hemorrhage who meet the eligibility criteria will receive intravitreal ranibizumab (0.5 mg/0.05 mL) under aseptic conditions. Patients will undergo comprehensive ophthalmic evaluation before treatment, including best-corrected visual acuity assessment, slit-lamp biomicroscopy, intraocular pressure measurement, fundus examination, and ocular imaging as clinically indicated, including optical coherence tomography, fluorescein angiography, or B-scan ultrasonography.
Participants will be followed after one week, one month, and monthly thereafter for 3 to 6 months. Additional ranibizumab injections may be administered after at least one month when clinically indicated. Panretinal photocoagulation may be performed once sufficient fundus visualization is obtained. Pars plana vitrectomy will be performed for worsening vitreous hemorrhage, persistent moderate or severe hemorrhage without adequate improvement, or the development of tractional retinal detachment involving the posterior pole.
The primary objectives are to evaluate improvement in best-corrected visual acuity and clearance of vitreous hemorrhage following intravitreal ranibizumab treatment. Secondary objectives include assessment of treatment-related adverse events and determination of the proportion of patients requiring pars plana vitrectomy during follow-up.
- Being tested
- Ranibizumab
- Keywords
- Diabetic Vitreous Hemorrhage, Proliferative Diabetic Retinopathy, Ranibizumab, Anti-VEGF, Pars Plana Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Ranibizumab (0.5 mg/0.05 mL) is administered by intravitreal injection under aseptic conditions. Before injection, topical anesthetic and 5% povidone-iodine are applied. The injection is performed using a 30-gauge needle through the inferotemporal pars plana approximately 4 mm posterior to the limbus. Additional injections may be administered after at least one month according to clinical response.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Ranibizumab | Experimental | Participants with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy receive intravitreal ranibizumab (0.5 mg/0.05 mL). Reinjection may be performed at least one month after the initial injection if clinically indicated. Participants are followed for 3 to 6 months to assess visual acuity, vitreous hemorrhage clearance, treatment-related adverse events, and the need for pars plana vitrectomy. Panretinal photocoagulation may be performed when adequate fundus visualization is achieved. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (BCVA)
Change in BCVA from baseline to the end of follow-up, measured using Snellen visual acuity and converted to logMAR for statistical analysis.
Measured: Baseline through 6 months
Secondary outcomes (1)
Need for Additional Ranibizumab Injections
Number and proportion of participants requiring reinjection based on persistent or incompletely resolved vitreous hemorrhage.
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Apr 2025
- Primary completion31 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Vitreous HemorrhageStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-arm interventional cohort study in which all eligible participants receive intravitreal ranibizumab injection. Participants are followed for 3 to 6 months to evaluate visual and anatomical outcomes, treatment-related complications, and the need for pars plana vitrectomy.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690800
- Sponsor's protocol ID
- BENHA-OPH-2025-RANI-VH-01
- Acronym
- RANI-VH
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage: A Prospective Interventional Cohort Study
- ClinicalTrials.gov ID
- NCT07690800
- Acronym / sponsor ID
- RANI-VH / BENHA-OPH-2025-RANI-VH-01
- Keywords
- Diabetic Vitreous Hemorrhage, Proliferative Diabetic Retinopathy, Ranibizumab, Anti-VEGF, Pars Plana Vitrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 8 Jul 2026 (actual)
- 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 prospective interventional cohort study evaluates the outcomes of intravitreal ranibizumab injection in patients with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy. The study aims to assess the effectiveness of ranibizumab in improving visual acuity, promoting vitreous hemorrhage clearance, reducing the need for pars plana vitrectomy, and evaluating treatment-related safety.
Eligible adult patients with diabetic vitreous hemorrhage will receive intravitreal ranibizumab according to the study protocol and will be followed for 3 to 6 months with serial ophthalmic examinations. Outcome measures include changes in best-corrected visual acuity, vitreous hemorrhage severity, treatment-related complications, and the proportion of patients requiring vitrectomy. Panretinal photocoagulation may be performed when adequate retinal visualization is achieved.
Detailed description
Diabetic vitreous hemorrhage is a common vision-threatening complication of proliferative diabetic retinopathy. Hemorrhage into the vitreous cavity results from fragile retinal neovascularization and may cause marked visual impairment while preventing adequate retinal examination and laser treatment. Although pars plana vitrectomy remains the standard treatment for persistent or non-clearing vitreous hemorrhage, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as a potential treatment option for selected patients.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), thereby reducing neovascular activity and vascular permeability. Suppression of VEGF may facilitate clearance of vitreous hemorrhage, improve visual acuity, allow subsequent panretinal photocoagulation, and reduce the need for vitrectomy.
This is a single-center prospective interventional cohort study conducted at the Ophthalmology Department of Benha University Hospital. Adult patients with diabetic vitreous hemorrhage who meet the eligibility criteria will receive intravitreal ranibizumab (0.5 mg/0.05 mL) under aseptic conditions. Patients will undergo comprehensive ophthalmic evaluation before treatment, including best-corrected visual acuity assessment, slit-lamp biomicroscopy, intraocular pressure measurement, fundus examination, and ocular imaging as clinically indicated, including optical coherence tomography, fluorescein angiography, or B-scan ultrasonography.
Participants will be followed after one week, one month, and monthly thereafter for 3 to 6 months. Additional ranibizumab injections may be administered after at least one month when clinically indicated. Panretinal photocoagulation may be performed once sufficient fundus visualization is obtained. Pars plana vitrectomy will be performed for worsening vitreous hemorrhage, persistent moderate or severe hemorrhage without adequate improvement, or the development of tractional retinal detachment involving the posterior pole.
The primary objectives are to evaluate improvement in best-corrected visual acuity and clearance of vitreous hemorrhage following intravitreal ranibizumab treatment. Secondary objectives include assessment of treatment-related adverse events and determination of the proportion of patients requiring pars plana vitrectomy during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-arm interventional cohort study in which all eligible participants receive intravitreal ranibizumab injection. Participants are followed for 3 to 6 months to evaluate visual and anatomical outcomes, treatment-related complications, and the need for pars plana vitrectomy.
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Ranibizumab | Experimental | Drug: RanibizumabParticipants with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy receive intravitreal ranibizumab (0.5 mg/0.05 mL). Reinjection may be performed at least one month after the initial injection if clinically indicated. Participants are followed for 3 to 6 months to assess visual acuity, vitreous hemorrhage clearance, treatment-related adverse events, and the need for pars plana vitrectomy. Panretinal photocoagulation may be performed when adequate fundus visualization is achieved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 20 to 70 years.
- Type 1 or Type 2 diabetes mellitus.
- Diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy.
- Treatment-naïve diabetic vitreous hemorrhage or recurrent/residual vitreous hemorrhage following previous panretinal photocoagulation.
- Phakic or pseudophakic eyes.
Key exclusion criteria (8 listed)
- Significant tractional retinal detachment or retinal traction requiring immediate surgery.
- Previous ocular surgery other than cataract surgery.
- Previous intravitreal pharmacologic treatment within the preceding 6 months.
- Any type of glaucoma.
- Active ocular infection or significant ocular surface disease.
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 |
|---|---|---|
| RanibizumabRanibizumab (0.5 mg/0.05 mL) is administered by intravitreal injection under aseptic conditions. Before injection, topical anesthetic and 5% povidone-iodine are applied. The injection is performed using a 30-gauge needle through the inferotemporal pars plana approximately 4 mm posterior to the limbus. Additional injections may be administered after at least one month according to clinical response. | Drug | Intravitreal Ranibizumab |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline through 6 months
Change in BCVA from baseline to the end of follow-up, measured using Snellen visual acuity and converted to logMAR for statistical analysis.
1 secondary outcome
Need for Additional Ranibizumab Injections
Time frame: Baseline through 6 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 8 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Diabetic Vitreous Hemorrhage and Intravitreal Injections, run by Benha University at 1 site in Egypt.
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 6 inclusion and 8 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 8 Jul 2026. 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 Egypt. 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?
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?
Change in Best-Corrected Visual Acuity (BCVA) (time frame: Baseline through 6 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 8 Jul 2026.