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Zuhua Sun, xiaoling liu; Efficacy of Initial Versus Delayed vPDT Combination With Conbercept in Patients With Symptomatic PCV: A Randomized Clinical Trial.. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4292.
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© ARVO (1962-2015); The Authors (2016-present)
To compare the initial versus delayed vPDT in combination with intravitreal injection of conbercept (IVC) in patients with symptomatic PCV.
This was a middle phase study data from a prospective, randomized, multicentre, 12-month trial (NCT02821520). Eighty patients were planned to be randomized 1:1 into the two groups. At baseline, patients in the initial combination group were treated with vPDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC only. Then vPDT was administered pro re nata (PRN) from month 3 to 11with the interval of less than 3 months, IVC was administered PRN monthly from month 1 to 11, respectively in both groups. All patients received relative full ophthalmic examinations, including BCVA, OCT, FA and ICGA prior to treatment and at month 3 and 12. The primary outcome measure was the mean change in BCVA and CRT at month 3. And then the proportion of polyps regression assessed by ICGA.
Forty-six patients were randomized from Jan to Oct 2017. Thirty-four patients were male. The mean age was 65.59±8.30 years old. The mean BCVA was 57.39±14.3 letters, and the mean CRT was 509.11±203.11μm at baseline. The baseline characteristics were nearly balanced except for the gender between the two groups. Twenty-seven patients have been followed up more than 3 months. Thirteen patients were in the initial combination group and 14 in delayed combination group. In the first 3 months, patients were only treated with IVC actually in the delayed group. At month 3, BCVA improved 2.62±8.93 and 9.57±6.32 letters in initial and delayed group, respectively. There was significant difference between the two groups (P=0.027). The mean reduction of CRT from baseline to month 3 was 230.85±220.05μm and 71.64±111.82μm in initial and delayed group, respectively. There was significant difference between the two groups (P=0.024). The proportion of patients whose ployps had been total regression at month 3 was 57.14 % and 21.43% in initial and delayed group, respectively. There was no significant difference between the two groups (P=0.053).
At month 3, delayed vPDT combination with IVC group was superior to initial combination group in the improvement of BCVA. But initial vPDT combination with IVC can quickly reduce the CRT than delayed combination group.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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