Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone for exudative age-related macular degeneration

No Clinical Trial Registration # | | Pan HT et al. (2020)

Pan HT, Wang JJ, Huang JL, et al. Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone for exudative age-related macular degeneration. J Int Med Res, 2020; 48(9):1-10.

Locations

Single-center study in China

Study Period

Not reported

Study Design

Prospective, randomized, controlled pilot study

Study Population

Characteristic:

Type of AMD:

Wet

AMD Stage:

3 (Late)

Total Sample Size:

38 patients (19 ranibizumab + cFXST, 19 ranibizumab alone)

Age:

Prospective, randomized, controlled pilot study

Sex (Male) n%:

Not reported

Experimental Group

Intervention Therapy:

Ranibizumab 0.5 mg intravitreal injection + Fufang Xueshuantong capsule (cFXST) daily

Dose & Frequency:

Three monthly intravitreal injections (0.5 mg ranibizumab), plus daily oral cFXST (4500 mg/day)

Age (Years):

59.0 ±4.0

Number of Patients:

19 randomized and treated

Male N %:

10 (52.6%)

Patients Followed Up:

Control Group

Intervention Therapy:

Ranibizumab 0.5 mg intravitreal injection alone

Dose & Frequency:

Three monthly intravitreal injections (0.5 mg ranibizumab), plus placebo capsules daily

Age (Years):

63.4 ±3.6

Number of Patients:

19 randomized and treated

Male N %:

11 (57.9%)

Patients Followed Up:

Follow-up Time: 3 months

Outcomes

Durability

Not reported

Vision

Best-Corrected Visual Acuity (BCVA) The mean (SD)change in BCVA (ETDRS letters) at 3 months:
• Ranibizumab + cFXST: +14.7 (2.8) letters
• Ranibizumab alone: +5.8 (3.1)letters
• Difference: p < 0.05 Vision Maintaining The proportion of patients with functional response (BCVA improvement) at 3 months:
• Ranibizumab + cFXST: 16/16
• Ranibizumab alone: 8/17
• Difference: p < 0.05

Other

Functional Response to Treatment At 3 months, the proportion of patients with functional response to treatment was also higher in the Ranibizumab + cFXST cohort than in the Ranibizumab alone cohort (16/16 vs. 8/17, P<0.05).

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Choroidal Neovascularization - Pigment Epithelial Detachment (CNV-PED) Complex The mean reduction in CNV-PED complex thickness at 3 months (primary outcome):
• Ranibizumab + cFXST: -36.1%
• Ranibizumab alone: -24.2%
• Difference: p < 0.05
• Ranibizumab + cFXST: 72 ±11μm
• Ranibizumab alone: 46± 9μm
• Difference: p >0.05 The mean reduction in CNV-PED complex thickness at 1 month:
• Ranibizumab + cFXST: -31.7%
• Ranibizumab alone: -19.7%
• Difference: p < 0.05
• Ranibizumab + cFXST: 63±11μm
• Ranibizumab alone: 27.1± 8.5μm
• Difference: p >0.05 Subretinal Fluid (SRF) Mean reduction in subretinal fluid (SRF) height:
• Both groups showed a significant reduction
• Differences were not statistically significant

Safety

Not reported

Outcomes

Conclusion

Oral cFXST significantly enhanced the efficacy of intravitreal ranibizumab in reducing CNV-PED thickness and improving BCVA at 3 months, with no reported adverse events. Larger studies are needed to confirm these findings.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns
Note: No information on the method of randomization or allocation concealment. “Baseline parameters were similar between the two cohorts…”

Missing Outcome Data

Low risk
Note: No missingness occurred in this short-period study.

Selection of the Reported Results

Some concerns Note: protocol was not publicly available

Deviations from Intended Observations

Low risk Note: “These measurements were performed by a masked examiner (Z.H.) at baseline and at each subsequent visit.” Patients were blinded to the treatment (placebo). No dropout occurred in this study; the ITT principle was applied.

Measurement of the Outcome

Low risk Note: “These measurements were performed by a masked examiner (Z.H.) at baseline and each subsequent visit.”

Overall

Some concerns