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Romdomized control study of the effectiveness of pro re nata resume with intra vitreal injection of ranibizumab or aflibercept for polypoidal choroidal vasculopathy

Romdomized control study of the effectiveness of pro re nata resume with intra vitreal injection of ranibizumab or aflibercept for polypoidal choroidal vasculopathy - The effectiveness of PRN resume with IVR or IVA for PCV

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017409
Enrollment
60
Registered
2015-05-07
Start date
2012-12-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypoidal choroidal vasculopathy

Interventions

Intravitreal injection of ranibizumab Intravitreal inection of aflibercept

Sponsors

Chiba University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Subfoveal polypoidal choroidal vasculopathy 2)The patient who did not received the monotherapy or the combination therapy such as anti-VEGF therapy,photo dynamic therapy,retinal photo coaguration or other therapy for retina. 3)The patient with fudus scopical serous retinal detachment, serous or hemorrhagic PED or subretinal hemorrhage. 4)The patinet with serous detachment more than 150 maicrometer at baseline. 5) The patient with 35 letters or more with ETDRS chart or 20/200 or more with Snellen Visual chart 6) The patient with lesion area less than 6230 maicrometer.

Exclusion criteria

Exclusion criteria: 1)The patient with dry AMD,wet AMD with typical AMD or wet AMD with retinal angiomatous proliferation. 2)The patinet with diabetic maculopathy, retinal vein occlusion,macular tellangiectasia. 3)The patient with subfoveal fibrosis or subfoveal atrophy. 4)The patient with moderate or severe cataract. 5)The patient with the possibility of development of secondary choroidal neovascularization, pahological myopia. 6)The patient who received intoraocular surgery 3 months before entry or filtrating surgery. 7)The patient who developed the inflamation around the eye 4 weeks before entry. 8)The patient who received vitrectomy. 9)The patient who developed reteinal epithelial tear. 10) The patient with below or with the passed history below; severe heart disease, severe peripheral vascular disease, severe renal failure, severe hepatic failure, cerebral infarction before entry or any surgery 1 month before entry. 11)The patient who received radiation therapy for the examination eye. 12)The patient with severe allergy with the contrast medium for fundus angio graphy. 13)The patient who is pregnant or is lactating.

Design outcomes

Primary

MeasureTime frame
The total number of dose with ranibizumab or aflibercept at 52 weeks.

Secondary

MeasureTime frame
1)Visual acuity with ETDRS chart. The ratio of the patients with visual acuity improvement with more than or within ten letters. 2)Subretinal hemorrhage,retinal pigment epitherial detachment and retinal atrophy by fundus photography. 3)Evaluation of fluorescein angiography:leakage from the lesion. 4)The ratio of the obstruction of plypoidal lesion at 12 weeks,24 weeks and 52 weeks. 5)The average of retinal sensitivity with MAIA 6)The average of central retinal thickness and and the amount of change of central retinal thickness with SD-OCT. 7)The average of central choroidal thickness and and the amount of change of central choroidal thickness with SD-OCT. 8)The evaluation of macular atrophic lesion with fundus auto fluorescein. 9)The ratio of patients with dry macular.

Countries

Japan

Contacts

Public ContactMasayasu Kitahashi

Chiba University Graduate School of Medicine Department of Ophthalmology and Visual Science

kitahashi_m@yahoo.co.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026