UnknownPhase 4

The Efficacy Assessment of Intravitreal Injection of Conbercept in Patients With Polypoidal Choroidal Vasculopathy (PCV)

China300 participantsStarted 2015-10

Plain-language summary

To assess the efficacy of intravitreal injection of 0.5 mg conbercept in patients with polypoidal choroidal vasculopathy (PCV) and explore the optimal route of administration.

Who can participate

Age range45 Years

SexALL

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Inclusion criteria

✓. BCVA is at least 19 and at most 83 alphabets (equivalent to a visual acuity of 20/25 to 20/400 for the Snellen Eye Chart);
✓. Patient has been diagnosed with active PCV on ICGA (confirmed by the third-party radiodiagnosis center); The diagnostic criteria for "active" PCV on ICGA are as follows: image indicates polypoid lesions as typical nodular high fluorescein area (observed stereoscopically) and also depicts one of the following angiographic findings: 1) nodular lesions surrounded by the weak halo; 2) nodular lesions nourished by abnormal vascular beds; and 3) nodular pulsation on dynamic ICGA;
✓. In case of the eye of interest complicated with subretinal hemorrhage or hemorrhage under the pigment epithelium, the range of hemorrhage should not be beyond the upper and lower vascular arcades in the macular area, and the total thickness of the central fovea (i.e., the thickness between the apex of the central fovea and the choriocapillary layer) is no more than 600 µm;
✓. Neither ocular media opacity nor miosis is noted to influence the fundus examination.

Exclusion criteria

✕. Amenorrhea for 12 months under the natural condition, or amenorrhea for 6 months under the natural condition and the serum FSH level of \> 40 mIU/ml;
✕. Six weeks after bilateral ovariectomy with/without hysterectomy;
✕. Use of the following one or more acceptable contraceptions:
✕. Ability to take reliable contraceptive measures over the study period and hold on to 30 days after study drug withdrawal (unacceptable contraceptive methods include: periodic continence - according to the calendar and ovulatory phase, body thermometry, post-ovulatory method, and coitus interruptus).

What they're measuring

Change of Best Corrected Visual Acuity

Timeframe: Baseline, 12th and 48th week

Trial details

NCT IDNCT03159884

SponsorChengdu Kanghong Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06

Contact for this trial

xiaoxin Li

dr_lixiaoxin@163.com

View on ClinicalTrials.gov More Polypoidal Choroidal Vasculopathy (PCV) trials