601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV) (NCT04922151) | Clinical Trial Compass
UnknownPhase 2
601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
China60 participantsStarted 2021-06-04
Plain-language summary
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sign informed consent form and willing to be visited at the time specified in the trial
* Male or Female, at least 18 years of age
* The study eye must meet the following criteria
* Diagnosed with active choroidal neovascularization secondary to pathological myopia
* BCVA score between 78 and 24 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320)
* No optometric media opacity and pupil abnormal
* BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
Exclusion Criteria:
* CNV secondary to other causes (except pathological myopia), such as neovascularage-related macular degeneration (nAMD), polypoid choroidal vascular disease (PCV), and secondary injury
* The fovea has fibrosis and organochemical foci or scar or atrophy that obviously involves the fovea and causes irreversible vision loss;
* Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to enrollment;
* PDT, Macular laser photocoagulation (focal/grid), vitrectomy or keratoplasty in the study eye at any time prior to baseline. Panretinal laser photocoagulation,YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline
* Aphakia (except IOL) or posterior capsular defect (except YAG posterio…
What they're measuring
1
Change from baseline in best-corrected visual acuity (BCVA) at Week 12