Retinopathy of Prematurity (ROP)
Conditions
Keywords
APROP, ROP, Ranibizumab, Aggressive posterior retinopathy of prematurity, Intra-vitreal Injection, Reactivation
Brief 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. 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.
Interventions
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.
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Arm Prospective non-randomized Interventional trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Weeks
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease regression following intravitreal ranibizumab | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Reactivation | From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age). | Incidence of AP-ROP reactivation requiring retreatment following initial disease regression |
| Time to first reactivation | Up to 72 weeks postmenstrual age. | Postmenstrual age (PMA) at the first episode of disease reactivation requiring retreatment. |
| Number of intravitreal ranibizumab injections | Up to 72 weeks postmenstrual age. | Number of intravitreal ranibizumab injections required per eye during the study period. |
| Complete retinal Vascularization | up to 72 weeks postmenstrual age | Proportion of eyes achieving complete peripheral retinal vascularization. |
| Treatment-related complications | From treatment until completion of follow-up (up to 72 weeks postmenstrual age). | Incidence of ocular or systemic complications associated with intravitreal ranibizumab treatment. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAhmed Mansour, MD, PhD
Ainshams University
Outcome results
None listed