Retinopathy of Prematurity (ROP)NCT07721298
Intravitreal Ranibizumab for Aggressive Posterior Retinopathy of Prematurity: A Prospective Interventional Case Series
A study testing Intravitreal Ranibizumab injection in people with Retinopathy of Prematurity (ROP), run by Ain Shams University at 1 site in Egypt.
Trial summary
Aggressive posterior retinopathy of prematurity (AP-ROP) is a severe form of retinopathy of prematurity that can progress rapidly and lead to retinal detachment and permanent vision loss if not treated promptly. Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- Intravitreal Ranibizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2021to 1 Feb 2025
- Phase
- Interventional
- 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 Up to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) according to the International Classification of Retinopathy of Prematurity.
- Gestational age ≤34 weeks or birth weight ≤2000 g.
- Infants with gestational age >34 weeks or birth weight >2000 g were eligible if they had additional systemic risk factors, including respiratory distress syndrome, patent ductus arteriosus, sepsis, necrotizing enterocolitis, need for mechanical ventilation, or blood transfusion.
- Infants whose parents or legal guardians provided written informed consent for treatment and follow-up.
Who cannot join
- Previous treatment for retinopathy of prematurity with intravitreal anti-VEGF therapy, laser photocoagulation, cryotherapy, or vitreoretinal surgery.
- Presence of retinal disease other than retinopathy of prematurity.
- Major congenital ocular anomalies that could interfere with retinal assessment or treatment response.
- Known genetic syndromes or systemic conditions judged by the investigators to significantly affect retinal vascular development or study follow-up.
- Media opacity or other ocular condition preventing adequate fundus examination or retinal imaging.
- Inability to complete the planned follow-up schedule.
- Refusal or withdrawal of consent by parents or legal guardians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy & Outcomes of Intra-vitreal Ranibizumab Injection in the Treatment of Aggressive Posterior Retinopathy of Prematurity
Aggressive posterior retinopathy of prematurity (AP-ROP) is a severe form of retinopathy of prematurity that can progress rapidly and lead to retinal detachment and permanent vision loss if not treated promptly. Although laser photocoagulation has traditionally been the standard treatment, intravitreal anti-vascular endothelial growth factor (anti-VEGF) medications such as ranibizumab have emerged as an alternative treatment because they may preserve the developing peripheral retina.
This study was designed to evaluate the effectiveness and safety of intravitreal ranibizumab in premature infants with AP-ROP. The study assessed the initial response to treatment, the frequency and timing of disease reactivation, the need for additional injections, retinal vascularization during follow-up, and treatment-related complications.
The information obtained from this study is intended to improve understanding of the role of ranibizumab in the management of AP-ROP and to guide follow-up strategies for infants receiving anti-VEGF therapy.
Read the detailed description
Detailed Description
Aggressive posterior retinopathy of prematurity (AP-ROP) is a rapidly progressive and vision-threatening subtype of retinopathy of prematurity (ROP) characterized by prominent plus disease, posterior retinal involvement, and rapid progression to retinal detachment if left untreated. Although laser photocoagulation has long been considered the standard treatment for severe ROP, its application in AP-ROP may be technically challenging because of the posterior location of the disease and is associated with permanent ablation of the peripheral retina, high myopia, and visual field constriction.
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as an alternative treatment that promotes rapid regression of retinal neovascularization while preserving peripheral retinal tissue. Ranibizumab is characterized by a shorter systemic and intravitreal half-life than other anti-VEGF agents, which may reduce systemic VEGF suppression but may also be associated with a higher risk of disease reactivation, necessitating prolonged surveillance after treatment.
This prospective interventional study was designed to evaluate the efficacy and safety of intravitreal ranibizumab as primary treatment for AP-ROP. The study aimed to assess the rate and timing of disease regression and reactivation, the need for additional intravitreal injections, retinal vascularization during follow-up, and anatomical outcomes. The study also sought to characterize the morphological patterns of disease reactivation and evaluate treatment-related ocular and systemic complications.
The findings are intended to contribute to the growing body of evidence regarding anti-VEGF therapy for AP-ROP and to provide additional data on long-term disease behavior following ranibizumab treatment in premature infants.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- Intravitreal Ranibizumab injection
- Keywords
- APROP, ROP, Ranibizumab, Aggressive posterior retinopathy of prematurity, Intra-vitreal Injection, Reactivation
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Ranibizumab injectionDrug
Intravitreal ranibizumab (0.25 mg in 0.025 mL) was administered under sterile conditions using a 30-gauge needle through the pars plicata, 1.5 mm posterior to the corneal limbus. Repeat injections were performed in eyes with disease reactivation according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Intra-vitreal injection of Ranibizumab | Experimental | Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) received intravitreal ranibizumab (0.25 mg/0.025 mL) as the primary treatment. Eyes were followed with serial ophthalmic examinations and retinal imaging to evaluate disease regression, reactivation, retinal vascularization, anatomical outcomes, and treatment-related complications. Eyes demonstrating disease reactivation received repeat intravitreal ranibizumab according to the study protocol. Receives: Drug: Intravitreal Ranibizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease regression following intravitreal ranibizumab
Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease resolution or involution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.
Measured: 1 week after the initial intravitreal ranibizumab injection
Disease regression following intravitreal ranibizumab
Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease involution \& resolution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.
Measured: 1 week after the initial intravitreal ranibizumab injection
Secondary outcomes (5)
Disease Reactivation
Incidence of AP-ROP reactivation requiring retreatment following initial disease regression
Measured: From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age).
Time to first reactivation
Postmenstrual age (PMA) at the first episode of disease reactivation requiring retreatment.
Measured: Up to 72 weeks postmenstrual age.
Number of intravitreal ranibizumab injections
Number of intravitreal ranibizumab injections required per eye during the study period.
Measured: Up to 72 weeks postmenstrual age.
Complete retinal Vascularization
Proportion of eyes achieving complete peripheral retinal vascularization.
Measured: up to 72 weeks postmenstrual age
Treatment-related complications
Incidence of ocular or systemic complications associated with intravitreal ranibizumab treatment.
Measured: From treatment until completion of follow-up (up to 72 weeks postmenstrual age).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start10 Sep 2021
- Primary completion1 Sep 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm Prospective non-randomized Interventional trial
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mansour , MD, PhD, Ain Shams University
- Investigators
- Ahmed Mansour, MD, PhD, Principal investigator, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721298
- Sponsor's protocol ID
- 163/2021
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study, including demographic characteristics, baseline clinical variables, treatment data, follow-up assessments, and outcome measures, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy & Outcomes of Intra-vitreal Ranibizumab Injection in the Treatment of Aggressive Posterior Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT07721298
- Acronym / sponsor ID
- 163/2021
- Conditions
- Retinopathy of Prematurity (ROP)
- Keywords
- APROP, ROP, Ranibizumab, Aggressive posterior retinopathy of prematurity, Intra-vitreal Injection, Reactivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 23 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.
Aggressive posterior retinopathy of prematurity (AP-ROP) is a severe form of retinopathy of prematurity that can progress rapidly and lead to retinal detachment and permanent vision loss if not treated promptly. Although laser photocoagulation has traditionally been the standard treatment, intravitreal anti-vascular endothelial growth factor (anti-VEGF) medications such as ranibizumab have emerged as an alternative treatment because they may preserve the developing peripheral retina.
This study was designed to evaluate the effectiveness and safety of intravitreal ranibizumab in premature infants with AP-ROP. The study assessed the initial response to treatment, the frequency and timing of disease reactivation, the need for additional injections, retinal vascularization during follow-up, and treatment-related complications.
The information obtained from this study is intended to improve understanding of the role of ranibizumab in the management of AP-ROP and to guide follow-up strategies for infants receiving anti-VEGF therapy.
Detailed description
Detailed Description
Aggressive posterior retinopathy of prematurity (AP-ROP) is a rapidly progressive and vision-threatening subtype of retinopathy of prematurity (ROP) characterized by prominent plus disease, posterior retinal involvement, and rapid progression to retinal detachment if left untreated. Although laser photocoagulation has long been considered the standard treatment for severe ROP, its application in AP-ROP may be technically challenging because of the posterior location of the disease and is associated with permanent ablation of the peripheral retina, high myopia, and visual field constriction.
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as an alternative treatment that promotes rapid regression of retinal neovascularization while preserving peripheral retinal tissue. Ranibizumab is characterized by a shorter systemic and intravitreal half-life than other anti-VEGF agents, which may reduce systemic VEGF suppression but may also be associated with a higher risk of disease reactivation, necessitating prolonged surveillance after treatment.
This prospective interventional study was designed to evaluate the efficacy and safety of intravitreal ranibizumab as primary treatment for AP-ROP. The study aimed to assess the rate and timing of disease regression and reactivation, the need for additional intravitreal injections, retinal vascularization during follow-up, and anatomical outcomes. The study also sought to characterize the morphological patterns of disease reactivation and evaluate treatment-related ocular and systemic complications.
The findings are intended to contribute to the growing body of evidence regarding anti-VEGF therapy for AP-ROP and to provide additional data on long-term disease behavior following ranibizumab treatment in premature infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm Prospective non-randomized Interventional trial
| Arm | Type | Receives |
|---|---|---|
| Intra-vitreal injection of Ranibizumab | Experimental | Drug: Intravitreal Ranibizumab injectionPremature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) received intravitreal ranibizumab (0.25 mg/0.025 mL) as the primary treatment. Eyes were followed with serial ophthalmic examinations and retinal imaging to evaluate disease regression, reactivation, retinal vascularization, anatomical outcomes, and treatment-related complications. Eyes demonstrating disease reactivation received repeat intravitreal ranibizumab according to the study protocol. |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) according to the International Classification of Retinopathy of Prematurity.
- Gestational age ≤34 weeks or birth weight ≤2000 g.
- Infants with gestational age >34 weeks or birth weight >2000 g were eligible if they had additional systemic risk factors, including respiratory distress syndrome, patent ductus arteriosus, sepsis, necrotizing enterocolitis, need for mechanical ventilation, or blood transfusion.
- Infants whose parents or legal guardians provided written informed consent for treatment and follow-up.
Key exclusion criteria (7 listed)
- Previous treatment for retinopathy of prematurity with intravitreal anti-VEGF therapy, laser photocoagulation, cryotherapy, or vitreoretinal surgery.
- Presence of retinal disease other than retinopathy of prematurity.
- Major congenital ocular anomalies that could interfere with retinal assessment or treatment response.
- Known genetic syndromes or systemic conditions judged by the investigators to significantly affect retinal vascular development or study follow-up.
- Media opacity or other ocular condition preventing adequate fundus examination or retinal imaging.
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 injectionIntravitreal ranibizumab (0.25 mg in 0.025 mL) was administered under sterile conditions using a 30-gauge needle through the pars plicata, 1.5 mm posterior to the corneal limbus. Repeat injections were performed in eyes with disease reactivation according to the study protocol. | Drug | Intra-vitreal injection of Ranibizumab |
Primary outcome
Disease regression following intravitreal ranibizumab
Time frame: 1 week after the initial intravitreal ranibizumab injection
Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease resolution or involution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.
Disease regression following intravitreal ranibizumab
Time frame: 1 week after the initial intravitreal ranibizumab injection
Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease involution \& resolution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.
5 secondary outcomes
Disease Reactivation
Time frame: From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age).
Time to first reactivation
Time frame: Up to 72 weeks postmenstrual age.
Number of intravitreal ranibizumab injections
Time frame: Up to 72 weeks postmenstrual age.
Complete retinal Vascularization
Time frame: up to 72 weeks postmenstrual age
Treatment-related complications
Time frame: From treatment until completion of follow-up (up to 72 weeks postmenstrual age).
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 23 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study, including demographic characteristics, baseline clinical variables, treatment data, follow-up assessments, and outcome measures, will be made available.
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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.
Ahmed Mansour, MD, PhD principal investigator
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Ranibizumab injection in people with Retinopathy of Prematurity (ROP), run by Ain Shams 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 4 inclusion and 7 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 23 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.
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?
Disease regression following intravitreal ranibizumab (time frame: 1 week after the initial intravitreal ranibizumab injection). The study lists 2 primary outcomes in all. 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 23 Jul 2026.