Clinical trial NCT03971162: Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
Official title: Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopic Choroidal Neovascularisation
Keywords: Choroidal Neovascularisation
Pathologic myopia
anti-VEGF
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV) is a common vision-threatening complication and often affects adults of working age. Intravitreal injection of any anti-vascular endothelial growth factor (VEGF) drugs would significantly suppress the activity of the CNV and finally improve the visual acuity. However, more than half of the patients would need one or more further injection for the recurrence or uncontrolled with 1+pro re nata (PRN) treatment within one year, and whether increasing the initial loading of intravitreal injection of anti-VEGF would be more efficacy for the controlling the PM-CNV remained unknown.


Eligibility criteria: Inclusion Criteria:

1. Patients who are aged ≥18 years, male or female
2. Active choroidal neovascularization secondary to pathologic myopia

   1. high myopia (defined as spherical equivalent ≤-6.0 diopter, AL≥26mm)
   2. presence of posterior changes compatible with pathologic myopia
   3. presence of active leakage from CNV, and presence of intra-retinal or subretinal fluid or increase of central retinal thickness
3. Presence of at least 1 of the following lesion types:

   1. subfoveal
   2. juxtafoveal with involvement of the central macular area
   3. extrafoveal with involvement of the central macular area
   4. margin of the optic disk with involvement of the central macular area
4. 24≤BCVA≤78, at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) like VA chart ( 20/32-20/320 Snellen equivalent)
5. Visual loss only due to the presence of any eligible types of CNV related to pathologic myopia, based on clinical ocular findings, fluorescein angiography (FA), and optical coherence tomography (OCT) data.
6. Patients who are willing to participant in this study and sign the informed consent

Exclusion Criteria:

* Pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time
* Intraocular treatment with corticosteroids or intraocular surgery within 3 months prior to randomization and treatment with anti-VEGF or verteporfin photodynamic therapy at any time in the study eye.
* Presence of CNV secondary to any cause other than pathologic myopia.
* Presence of active infectious disease or intraocular inflammation, active or suspected periocular infection or iris neovascularization in either eye at the time of enrollment.
* Pregnant or nursing women.
* Patients with other coexisting ocular diseases, such as an abnormal cornea or a corneal infection, iridocorneal endothelial syndrome, anterior segment dysgenesis, nanophthalmos, chronic or recurrent uveitis, ocular cancer, trauma, central retinal vein occlusion, central retinal artery occlusion, and retinal detachment).
* Patients with severe systemic disease and high risk when receiving intravitreous injection of anti-VEGF, such as diabetes mellitus, hypertension, end-stage cardiac disease, nephropathy, respiratory disease, cancer and HIV.
* Patients had stroke, transient ischemic attack, myocardial infarction, acute congestive heart failure within 6 months prior to randomization

Primary outcomes:
measure: BCVA change
timeFrame: 12 months
Secondary outcomes:
measure: Recurrence rate of PM-CNV
timeFrame: 12 months
measure: BCVA at 3 years
timeFrame: 36 months
measure: The change of CNV size
timeFrame: 12 months
measure: The treatment exposure
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: lin lu
role: PRINCIPAL_INVESTIGATOR
References: